Akorn Codeine Oral Solution: Recall, Discontinuation, Counterfeits, and What Comes Next

Editorial Note: This article was researched and written against publicly available guidance from the FDA, DEA, CDC, SAMHSA, and U.S. Bankruptcy Court records. It is intended for educational and public safety purposes only and does not constitute medical, legal, or pharmaceutical advice. Always consult a licensed healthcare professional for guidance specific to your situation.

Key Facts at a Glance

What Was Akorn Codeine Oral Solution?

Akorn Codeine Oral Solution was a prescription opioid medication manufactured by Akorn Operating Company LLC, one of the United States’ largest generic pharmaceutical producers. The product line included several codeine-containing formulations—most notably acetaminophen and codeine phosphate oral solution and promethazine and codeine oral solution—used clinically to manage mild-to-moderate pain and suppress cough in eligible patients under physician supervision.

What was Akorn Codeine Oral Solution?
Akorn Codeine Oral Solution was a prescription opioid manufactured by Akorn Operating Company LLC. It is no longer legally produced or distributed in the United States. Following the company’s Chapter 7 bankruptcy filing on February 23, 2023, all manufacturing permanently ceased. On May 4, 2023, the FDA announced a voluntary consumer-level recall of all eligible within-expiry Akorn human drug products. Any newly marketed Akorn-branded codeine syrup is counterfeit.

Akorn’s generic pharmaceutical portfolio supplied hospitals, retail pharmacies, and specialty dispensers across the country. Its codeine oral solution products occupied a meaningful share of the generic opioid liquid market. Their permanent removal from the supply chain—combined with escalating counterfeit activity exploiting the Akorn brand name—created both a clinical access gap and a significant, ongoing public health risk affecting patients, prescribers, and regulators nationwide.

This article provides a clinically accurate, authoritative account of what happened to Akorn Pharmaceuticals, what the FDA recall means for patients, why counterfeit Akorn codeine syrup represents a serious and growing danger, how to verify legitimate generic alternatives, and what actionable steps patients and clinicians should take.

Sources: FDA Recall Notice — Akorn Operating Company LLC (May 4, 2023) | FDA MedWatch | U.S. Bankruptcy Court — Akorn Operating Company LLC, Chapter 7 Filing, February 2023

Akorn Codeine Oral Solution is no longer legally manufactured or sold in the United States. After Akorn Operating Company LLC filed for Chapter 7 bankruptcy on February 23, 2023, all manufacturing permanently ceased. The FDA announced a nationwide voluntary recall of all eligible within-expiry Akorn human drug products on May 4, 2023. Any newly marketed Akorn-branded codeine oral solution is definitionally counterfeit and should be reported to the FDA MedWatch program immediately.

Akorn Codeine Oral Solution was a prescription opioid manufactured by Akorn Operating Company LLC. Following Chapter 7 bankruptcy on February 23, 2023, all manufacturing ceased and the FDA issued a voluntary recall on May 4, 2023, because required quality assurance programs could no longer be maintained. No legitimate Akorn-branded codeine products are currently produced or legally distributed. Products offered under the Akorn name through unauthorized channels are counterfeit and may contain fentanyl, nitazenes, or other lethal adulterants. Consult a licensed healthcare professional for FDA-approved alternatives. Report suspected counterfeits to FDA MedWatch at 1-800-FDA-1088.

Akorn Codeine Oral Solution: Timeline of Key Events

A chronological account of Akorn’s regulatory history and eventual closure is essential context for understanding both the recall and the counterfeit risk that followed.

 What is the Akorn Codeine Oral Solution recall timeline?
Akorn’s regulatory difficulties began in 2017 with an FDA Warning Letter citing CGMP violations. After years of compounding financial and compliance pressure, the company filed for Chapter 7 bankruptcy on February 23, 2023. The FDA announced a voluntary recall of all eligible within-expiry Akorn human drug products on May 4, 2023. Since closure, the Akorn brand has been actively exploited by counterfeit producers distributing illicit opioid products through unauthorized channels.

What Happened to Akorn Pharmaceuticals?

Akorn Operating Company LLC filed for Chapter 7 bankruptcy on February 23, 2023, and permanently ceased all pharmaceutical manufacturing and distribution. On May 4, 2023, the FDA announced a voluntary consumer-level recall of all eligible within-expiry Akorn human drug products because the company could no longer maintain FDA-required CGMP compliance, drug stability monitoring, or adverse event surveillance programs necessary to ensure product safety, identity, strength, quality, and purity.

Akorn Operating Company LLC’s collapse was not sudden—it was the culmination of years of compounding regulatory and financial pressure. The company had been among the largest U.S. generic pharmaceutical manufacturers, with a product portfolio spanning ophthalmic solutions, injectable medications, and oral liquid formulations including its codeine-containing products.

Akorn’s regulatory difficulties predated its bankruptcy by several years. In 2017, the FDA issued a Warning Letter to Akorn’s Somerset, New Jersey facility citing significant CGMP violations. Subsequent inspections identified persistent quality control deficiencies across multiple manufacturing sites, making Akorn the subject of prolonged FDA scrutiny at a time when the company was simultaneously contending with financial deterioration, generic pharmaceutical pricing pressure, and mounting legal liabilities.

By February 2023, continued operations were no longer financially or operationally viable. The Chapter 7 filing—which provides for complete liquidation rather than reorganization—signaled a permanent end to Akorn as a functioning pharmaceutical manufacturer. Unlike Chapter 11 bankruptcy, which allows a company to restructure and potentially resume operations, Chapter 7 results in the orderly wind-down and asset liquidation of the filing entity with no path to resumption.

The FDA’s May 4, 2023 recall addressed the critical patient safety consequence of this closure: without functioning quality assurance infrastructure, no mechanism remained to ensure that remaining Akorn inventory met federal standards for drug identity, purity, strength, and stability. The recall covered all eligible within-expiry Akorn human drug products—encompassing codeine oral solution formulations alongside hundreds of other products across the company’s portfolio.

The practical impact on the U.S. pharmaceutical supply chain was immediate. Akorn had been a significant supplier of generic oral liquid medications. Its exit created supply gaps across multiple therapeutic categories, with codeine oral solutions among the most clinically impactful given existing tightness in the prescription opioid liquid market.

Source: FDA Recall Announcement — Akorn Operating Company LLC, May 4, 2023

Is Akorn Pharma Out of Business?

Yes. Akorn Operating Company LLC permanently ceased all pharmaceutical manufacturing and distribution following its Chapter 7 bankruptcy filing on February 23, 2023. The company no longer exists as an operational pharmaceutical entity. No legitimate Akorn-branded prescription medications are currently being produced, distributed, or legally sold anywhere in the United States.

This is not a temporary suspension, a product line reduction, or a partial wind-down. Chapter 7 bankruptcy proceedings result in complete dissolution of the business entity. Akorn Operating Company LLC has no manufacturing facilities, no active workforce, no functioning quality systems, and no legal authority to produce or distribute regulated pharmaceutical products.

For patients, pharmacists, and prescribers, the operational implication is unambiguous: there is no legitimate source for newly produced Akorn-branded medication of any kind. Any Akorn-labeled pharmaceutical product encountered in the current marketplace—whether offered through online platforms, social media, informal networks, or unverified retail channels—cannot be a legitimately manufactured Akorn product. It must be treated as suspected counterfeit and reported to the appropriate authorities immediately.

Akorn Cough Syrup Discontinued: What Patients Need to Know

Is Akorn cough syrup discontinued?
Yes. Akorn cough syrup—including promethazine and codeine oral solution—was permanently discontinued following Akorn Operating Company LLC’s Chapter 7 bankruptcy in February 2023. The FDA subsequently recalled all eligible within-expiry Akorn human drug products on May 4, 2023. Akorn cough syrup is no longer legally manufactured, distributed, or available through any legitimate pharmacy channel in the United States.

Patients who previously relied on Akorn’s promethazine-codeine or other cough syrup formulations should contact their prescribing clinician to discuss FDA-approved alternatives. Several active generic manufacturers continue to produce codeine-containing and non-opioid antitussive formulations. No patient should attempt to source Akorn-branded cough syrup through informal, online, or non-pharmacy channels—doing so presents a significant risk of exposure to counterfeit products containing fentanyl or other lethal adulterants.

The Akorn Promethazine Codeine Recall

Promethazine and codeine oral solution was among Akorn’s most recognized product lines. The combination of promethazine hydrochloride—a first-generation antihistamine with sedative and antiemetic properties—and codeine phosphate—a Schedule V opioid agonist in oral solution form—was widely prescribed for symptomatic cough relief and upper respiratory symptoms in appropriate adult patients.

 Was Akorn promethazine codeine recalled?
Yes. Akorn promethazine and codeine oral solution was included in the FDA’s May 4, 2023 nationwide voluntary recall of all eligible within-expiry Akorn human drug products. The recall was necessitated by Akorn’s permanent closure and consequent inability to maintain FDA-required pharmaceutical quality assurance standards. No legitimately manufactured Akorn promethazine-codeine product is currently available.

The promethazine-codeine formulation carried clinical and regulatory complexity beyond standard opioid oral solutions. Promethazine is a potent CNS depressant with documented respiratory depressant properties, and its combination with codeine—itself a dose-dependent respiratory depressant—creates synergistic CNS depression risk. The FDA had previously issued safety communications restricting promethazine-codeine use in pediatric patients and warning about misuse potential in the context of recreational “lean,” “purple drank,” and “sizzurp” culture (addressed in detail below).

The recall of Akorn’s promethazine-codeine products compounded an already challenging supply environment, requiring prescribers and dispensers who had relied on the Akorn formulation to source from remaining active manufacturers or transition patients to clinically appropriate alternatives.

Akorn Codeine Oral Solution Recall: What Patients Need to Know

The FDA’s May 4, 2023 recall of Akorn human drug products was classified as a voluntary consumer-level recall—meaning it applied to products that had already reached end consumers, not solely to products held in the distribution chain.

What should someone do with recalled Akorn medication?
Patients should stop using recalled Akorn medication unless specifically advised otherwise by their healthcare provider, consult a pharmacist or prescribing clinician promptly, and dispose of the product through an authorized DEA drug take-back program or in accordance with FDA disposal guidance. Do not transfer, sell, or give recalled controlled substances to any other person. Report adverse events or quality concerns to FDA MedWatch at 1-800-FDA-1088.

Key facts about the recall:

• Recall date: May 4, 2023
• Recalling firm: Akorn Operating Company LLC (in Chapter 7 bankruptcy proceedings)
• Scope: All eligible within-expiry Akorn human drug products, including codeine oral solution formulations
• Reason: Permanent cessation of operations and consequent inability to maintain FDA-required quality assurance systems, including CGMP compliance, drug stability monitoring, and adverse event surveillance
• Classification: Voluntary consumer-level recall

What this means for patients currently holding Akorn medication:

Patients who have unexpired Akorn-labeled medications in their possession should consult a pharmacist or licensed healthcare provider before continuing use. While the recall does not establish that every unit in patient possession is immediately unsafe, the absence of functioning quality assurance infrastructure means that ongoing conformance to labeled specifications—including potency, stability, and freedom from contamination—cannot be verified or guaranteed.

Safe disposal options:

• The DEA Authorized Drug Take-Back Locator identifies local collection sites for controlled substances
• The FDA Drug Disposal Guidance provides FDA-approved flush list instructions for opioids when take-back options are unavailable
• The DEA’s National Take-Back Day events provide periodic collection at thousands of authorized sites nationwide

Report adverse events or quality concerns related to Akorn products to FDA MedWatch online or at 1-800-FDA-1088.

Counterfeit Akorn Codeine Syrup: A Serious and Growing Public Health Risk

The permanent closure of Akorn Operating Company LLC created a predictable and dangerous opportunity for counterfeit operators. The Akorn brand name—recognized by patients, pharmacists, and illicit drug markets alike—is now being actively exploited by criminal enterprises producing and distributing fraudulent products under the Akorn label.

What is counterfeit Akorn codeine syrup?
Counterfeit Akorn codeine syrup refers to fraudulent products using Akorn’s brand name, labeling, or packaging to appear legitimate while being manufactured by illegal operations with no pharmaceutical oversight. Because Akorn no longer exists as a manufacturer, any “new” Akorn-branded codeine syrup is definitionally counterfeit. Laboratory analyses of similar counterfeit opioid products have confirmed the presence of fentanyl, nitazenes, incorrect codeine concentrations, and other adulterants that dramatically elevate overdose and death risk.

Why Counterfeit Codeine Syrup Is Particularly Dangerous

The danger of counterfeit opioid products is not merely that they are unregulated—it is that their composition is fundamentally unknowable to the consumer. Counterfeit opioid products seized and analyzed by law enforcement and public health laboratories have revealed:

• Fentanyl substitution or adulteration: Fentanyl is 50–100 times more potent than morphine by weight. A counterfeit codeine syrup containing even trace amounts of fentanyl can deliver a fatal dose with no perceptible difference in the product’s appearance, color, or taste.
• Nitazene contamination: Nitazenes—including metonitazene and isotonitazene—are a class of synthetic opioids structurally unrelated to traditional opioids, substantially more potent than fentanyl in some cases, and not reliably reversed by standard naloxone doses. Their presence in counterfeit opioid liquid products is an escalating and underrecognized public health threat.
• Incorrect active ingredient concentrations: Counterfeit products may contain far more or far less codeine than labeled, making any dose estimation impossible and dangerous.
• Unidentified contaminants: Uncontrolled manufacturing conditions introduce risk of microbial contamination, heavy metal exposure, and undisclosed chemical adulterants.

The CDC and DEA have both issued sustained public warnings about the proliferation of fentanyl- and nitazene-adulterated counterfeit pharmaceutical products. The risk of fatal overdose from a single exposure to counterfeit opioid liquid is documented, statistically significant, and rising.

Counterfeit Warning Signs: Quick-Reference Checklist

Use this checklist to identify suspected counterfeit Akorn or other pharmaceutical products:

Product and Packaging Red Flags:

• Any newly produced product bearing the Akorn brand name (Akorn has not manufactured products since February 2023)
• Missing, incomplete, or inconsistent lot numbers
• Blurry, misaligned, or low-resolution printed labeling
• Spelling errors or grammatical inconsistencies on product labels
• Tamper-evident seal that appears broken, replaced, or absent
• Colors, viscosity, or odor inconsistent with the known formulation
• Labeling that does not include required FDA-format prescribing information

Transaction and Source Red Flags:

• Products offered for sale without a valid prescription
• Purchase channels including social media platforms, encrypted messaging applications, or unverified websites
• Sellers unable to provide verifiable pharmacy licensure or dispensing documentation
• Pricing significantly below known market rate for legitimate prescription medication
• Delivery through non-pharmacy channels—private individuals, peer networks, or social media transactions

Verification Red Flag:

• Product cannot be verified through the FDA Orange Book or the dispensing pharmacy’s licensed wholesaler documentation

If you suspect a counterfeit product, do not use it. Retain the product and its packaging if safe to do so, and report immediately to FDA MedWatch at 1-800-FDA-1088.

How to Verify a Legitimate Generic Manufacturer and Safe Pharmacy

With Akorn no longer operational, patients and clinicians must be equipped to verify that alternative codeine oral solution products come from legitimate, FDA-approved sources.

How can patients verify a legitimate generic codeine manufacturer?
Patients can verify FDA-approved generic codeine oral solution manufacturers through the FDA Orange Book, which lists all approved drug products and their manufacturers. Pharmacies dispensing legitimate generics source products exclusively from licensed wholesale distributors. Patients should only obtain prescription medications from pharmacies verifiable through the National Association of Boards of Pharmacy (NABP) or those operating under a state board of pharmacy license.

How to Verify FDA-Approved Generic Manufacturers

1. FDA Orange Book: The FDA Orange Book is the authoritative database of FDA-approved drug products with therapeutic equivalence evaluations. Search by active ingredient (codeine phosphate, promethazine hydrochloride) to identify approved manufacturers and their specific product approvals.
2. DailyMed: The National Library of Medicine’s DailyMed database contains current FDA-approved labeling for all marketed drugs, searchable by manufacturer. An active product listing in DailyMed confirms current FDA approval status.
3. RxNorm: The NLM’s RxNorm provides standardized drug nomenclature and can be used to cross-reference product names and formulations against approved entries.
4. United States Pharmacopeia (USP): USP standards define quality benchmarks for pharmaceutical ingredients and finished products. Medications from manufacturers that comply with USP monograph standards provide an additional layer of quality assurance.

Safe Online Pharmacy Checklist (NABP Standards)

Not all online pharmacies operate legally or safely. The National Association of Boards of Pharmacy (NABP) maintains verified directories of legitimate online pharmacies. Before obtaining any prescription medication online:

• Verify the .pharmacy domain: NABP’s .pharmacy verified program identifies websites meeting U.S. pharmacy practice standards
• Confirm state licensure: The dispensing pharmacy must hold a valid license in the state where the patient resides
• Require a valid prescription: Legitimate pharmacies will always require a prescription from a licensed prescriber before dispensing any controlled substance
• Avoid “no prescription required” sites: Any online pharmacy offering controlled substances without a valid prescription is operating illegally
• Check NABP’s Not Recommended List: NABP maintains a database of websites identified as operating outside U.S. pharmacy laws and standards

How Pharmacists Verify Legitimate Manufacturer Sources

Licensed pharmacies obtain pharmaceutical products exclusively through FDA-registered wholesale distributors—not through retail channels, online marketplaces, or informal networks. Pharmacists can verify manufacturer legitimacy through:

• Wholesaler documentation: Licensed distributors maintain chain-of-custody records traceable to the manufacturer’s FDA-registered facility
• FDA Establishment Registration: Manufacturers of prescription drugs must be registered with the FDA; this status is searchable through the FDA Establishment Registration & Drug Listing database
• State Board of Pharmacy oversight: State boards regulate pharmacy purchasing practices and can investigate suspected illegitimate sourcing

Sources: NABP — .pharmacy verified program | FDA Orange Book | DailyMed — NLM | USP

Acetaminophen and Codeine Phosphate Oral Solution: Akorn Formulation Overview

Akorn’s acetaminophen and codeine phosphate oral solution was a Schedule III controlled substance under the Controlled Substances Act, combining acetaminophen (a non-opioid analgesic and antipyretic) with codeine phosphate (an opioid agonist) in a liquid formulation designed for patients requiring oral liquid delivery.

What was acetaminophen and codeine phosphate oral solution used for?
Acetaminophen and codeine phosphate oral solution is indicated for short-term relief of mild-to-moderate pain in patients for whom a liquid opioid formulation is clinically appropriate. It combines the analgesic effects of acetaminophen with the opioid analgesic properties of codeine phosphate. The Akorn-manufactured version is no longer available. FDA-approved generics from active manufacturers remain on the market and are verifiable through the FDA Orange Book.

Codeine is a prodrug metabolized in the liver by the CYP2D6 enzyme into morphine, which is responsible for its analgesic and antitussive effects. This metabolic pathway creates clinically important interindividual variability: CYP2D6 ultra-rapid metabolizers convert codeine to morphine at an accelerated rate, producing risk of morphine toxicity even at standard doses—a pharmacogenomic consideration central to the FDA’s 2017 black box warning restricting codeine use in children following adenotonsillectomy and in nursing mothers.

The liquid formulation is particularly relevant for pediatric patients, elderly patients with dysphagia, and individuals in post-surgical recovery. The loss of Akorn’s version reduced generic market supply and placed additional demand pressure on remaining active manufacturers.

Opioid Oral Solution Side Effects

Codeine-containing oral solutions share a well-characterized adverse effect profile consistent with opioid agonists, with additional considerations specific to liquid formulations and combination products.

What are the side effects of opioid oral solutions like codeine?
Common side effects of codeine oral solution include nausea, vomiting, constipation, drowsiness, dizziness, and respiratory depression. Serious risks include dose-dependent respiratory depression, physical dependence, and opioid use disorder. Combination products containing promethazine carry additional risk of severe sedation and compounded respiratory depression. All codeine products carry an FDA black box warning addressing respiratory depression, death in children, and neonatal opioid toxicity.

Common Side Effects

• Gastrointestinal effects: Nausea, vomiting, and constipation are the most frequently reported adverse effects. Constipation is a dose-dependent, pharmacologically expected consequence of opioid-mediated reduction in gastrointestinal motility and does not typically diminish with continued use.
• CNS effects: Drowsiness, sedation, cognitive impairment, and dizziness are characteristic of opioid CNS depression and are substantially amplified when codeine is combined with other CNS depressants including alcohol, benzodiazepines, or antihistamines such as promethazine.
• Respiratory depression: The most clinically serious adverse effect of opioid analgesics and the proximate cause of opioid overdose fatality. Risk is substantially elevated in opioid-naive patients, elderly patients, those with compromised pulmonary function, and individuals taking concurrent CNS depressants.
• Dependence and withdrawal: Physical dependence can develop with regular use. Abrupt discontinuation following chronic use may precipitate opioid withdrawal syndrome characterized by anxiety, diaphoresis, myalgia, gastrointestinal cramping, and insomnia.
• Opioid use disorder: As Schedule III and Schedule V controlled substances, codeine oral solutions carry recognized potential for misuse and development of opioid use disorder.

FDA Black Box Warning

The FDA has issued a black box warning—the most serious warning level in U.S. pharmaceutical labeling—for codeine-containing products, addressing:

• Risk of respiratory depression and death in children, particularly following adenotonsillectomy
• Risk of neonatal opioid toxicity in infants of nursing mothers who are CYP2D6 ultra-rapid metabolizers
• Contraindication in children under 12 for pain management
• Contraindication in patients under 18 following adenotonsillectomy

Source: FDA Drug Safety Communication — Codeine (2017)

Purple Drank: Street Name History and Public Health Context

Any comprehensive account of codeine oral solution must address the well-documented intersection of prescription promethazine-codeine syrup with recreational drug culture. This context is essential for clinicians, public health professionals, and policymakers evaluating the full scope of risks associated with the Akorn recall and the subsequent emergence of counterfeit codeine syrup.

 What is purple drank?
“Purple drank”—also known as “lean,” “sizzurp,” or “dirty Sprite”—is a recreational drug preparation made by mixing prescription promethazine-codeine cough syrup with carbonated soft drinks, typically with hard candy added. The combination produces CNS and opioid depression including sedation, euphoria, and dissociation. Originating in Houston, Texas in the early 1990s, it spread nationally through association with hip-hop culture and has been linked to multiple overdose deaths. The specific formulation involved—promethazine-codeine oral solution—is exactly the product Akorn manufactured and that counterfeit operators are now exploiting.

Origins and Cultural Spread

The recreational use of promethazine-codeine syrup in beverages originated in Houston, Texas in the early 1990s and spread nationally through prominent association with hip-hop and rap music. References in high-profile music dramatically amplified cultural visibility and recreational appeal, particularly among adolescents and young adults. The deep purple color of many promethazine-codeine formulations gave rise to the “purple drank” nomenclature.

The beverage’s sedating, dissociative effects result from the combined CNS depression of codeine—via hepatic conversion to morphine—and promethazine’s potent first-generation antihistamine sedation. Users report euphoria, altered time perception, slowed speech, and involuntary muscle relaxation.

Overdose Risk and Documented Deaths

The physiological risk profile of purple drank is severe. The combination of a respiratory-depressant opioid with a potent sedating antihistamine creates compounded CNS depression that is dose-sensitive, highly variable, and poorly predictable—particularly when alcohol or other substances are added. Critically, incremental increases in the promethazine-codeine dose do not produce proportional increases in subjective euphoria but do produce proportional increases in respiratory depression risk, dramatically narrowing the margin between intoxication and fatal overdose.

High-profile deaths attributed to purple drank—including DJ Screw (2000) and Pimp C (2007)—brought the practice into sustained national public health focus and underscored the lethal potential of what popular culture had widely depicted as low-risk.

Why Counterfeit Codeine Syrup Is Especially Deadly in This Context

Cultural familiarity with purple drank creates a uniquely dangerous vulnerability in the current counterfeit environment. Individuals seeking promethazine-codeine syrup through illicit channels may obtain counterfeit products without recognizing that the product bears no pharmacological relationship to legitimately manufactured codeine syrup. When those counterfeit products contain fentanyl or nitazenes rather than codeine, the physiological consequences are radically different—and potentially lethal at doses the user believes to be safe based on prior experience with the genuine formulation.

This dynamic—experienced users applying historical dose intuitions to counterfeit products with an entirely different active ingredient profile—is a well-documented driver of fentanyl-related overdose deaths across multiple drug categories and represents one of the most urgent public health dimensions of Akorn’s brand exploitation by illicit operators.

Sources: CDC — Overdose Prevention | DEA — Fentanyl Awareness

Codeine Oral Solution Generic Manufacturers: Who Still Makes It?

The exit of Akorn from the generic pharmaceutical market created immediate supply pressure on codeine oral solution products. FDA-approved manufacturers continue to produce these formulations, and prescribers and pharmacists should be aware of currently active sources.

Who manufactures generic codeine oral solution now that Akorn is gone?
FDA-approved generic codeine oral solution continues to be manufactured by active pharmaceutical companies including Padagis and Pharmaceutical Associates Inc. (PAI), among others. Availability varies by formulation, strength, and regional distribution. The FDA Orange Book is the authoritative resource for verifying current approval status of any generic codeine formulation. Pharmacists are best positioned to identify real-time availability at the dispensing level.

Key Active Manufacturers

Padagis (formerly Perrigo Pharmaceutical) is among the major generic manufacturers producing codeine-containing oral liquid products under current FDA oversight and CGMP-compliant manufacturing infrastructure.

Pharmaceutical Associates Inc. (PAI) is an established manufacturer of oral liquid pharmaceutical formulations, including controlled substances, with an active FDA product portfolio.

Additional manufacturers may hold FDA approval for specific codeine oral solution formulations. The FDA Orange Book is the definitive, searchable resource for verifying the regulatory approval status of any generic codeine formulation and identifying the full list of approved manufacturers.

The Prescription Cough Syrup Shortage Context

The Akorn closure did not occur in a pharmaceutical supply vacuum. The United States has experienced documented, ongoing shortages of prescription oral liquid medications—with controlled substance formulations among the most persistently affected categories.

Contributing structural factors include:

• DEA production quotas: Under the Controlled Substances Act, the DEA sets annual aggregate production quotas for Schedule II–V controlled substances, limiting total domestic manufacturing capacity and creating supply ceilings that are structurally difficult to increase rapidly in response to market disruptions
• Manufacturing consolidation: Significant consolidation in the generic pharmaceutical industry has reduced the number of manufacturers producing any given product, decreasing supply chain redundancy
• Increased demand: Population aging, expanded prescription access, and documented illicit market demand have collectively increased pressure on codeine oral solution supply
• Regulatory compliance pressures: Manufacturers operating under FDA Warning Letters, consent decrees, or CGMP remediation requirements may face production interruptions that reduce available supply

Patients and prescribers experiencing difficulty accessing codeine oral solution alternatives should consult the FDA Drug Shortages Database for current status information.

Source: FDA Drug Shortages — Current List

Alternatives to Akorn Codeine Oral Solution

Patients previously managed on Akorn codeine oral solution should work directly with their prescribing clinician to identify the most clinically appropriate alternative. No controlled substance substitution should be made without professional guidance.

What are the alternatives to Akorn Codeine Oral Solution?
Clinicians may prescribe FDA-approved generic codeine oral solutions from active manufacturers such as Padagis or Pharmaceutical Associates Inc. For cough suppression, non-opioid alternatives including dextromethorphan, guaifenesin, or benzonatate may be appropriate depending on clinical presentation and indication. For pain management, alternative analgesic strategies should be individualized based on pain etiology, severity, patient history, and current evidence-based opioid prescribing guidelines. All substitutions require clinician oversight.

Pharmacological Alternatives by Indication

For codeine oral solution (pain management):

• Generic acetaminophen and codeine phosphate oral solution from active FDA-approved manufacturers
• Hydrocodone oral solution where clinically appropriate and consistent with state prescribing regulations
• Non-opioid analgesic regimens for patients where opioid therapy can be safely reduced or eliminated, consistent with current pain management evidence and CDC guidelines

For promethazine-codeine (cough suppression):

• Dextromethorphan-containing products (non-controlled, widely available OTC and Rx)
• Guaifenesin-based expectorants
• Benzonatate capsules (prescription, non-opioid antitussive)
• Other FDA-approved antitussive formulations appropriate to the specific clinical indication

For patients with opioid use disorder in context:
Patients who developed opioid use disorder related to codeine syrup use—including those involved in recreational use—should be connected with evidence-based treatment. SAMHSA’s National Helpline provides free, confidential referrals 24/7 at 1-800-662-4357.

How to Report Suspected Counterfeit Akorn Products

How can consumers report counterfeit medications?
Suspected counterfeit medications should be reported to FDA MedWatch at 1-800-FDA-1088 or online at FDA.gov/MedWatch. The DEA Diversion Control Division should be contacted for cases involving suspected illegal manufacture or distribution of controlled substances. Local law enforcement should be notified in cases of active sale. Do not use the suspected product. Retain the product and packaging as evidence to support investigation.

Step-by-step reporting protocol:

1. Do not use the product. Retain it and its original packaging if it is safe to do so—physical evidence materially supports regulatory and law enforcement investigation.
2. Report to FDA MedWatch: Online reporting form or 1-800-FDA-1088. Both healthcare professionals and consumers may submit reports.
3. Report to the DEA Diversion Control Division: The DEA investigates illegal manufacture and distribution of controlled substances. Reports may be submitted online or through the nearest DEA field office.
4. Report to the FDA Office of Criminal Investigations (OCI): The FDA OCI specifically investigates fraud and criminal activity involving FDA-regulated products, including counterfeit pharmaceuticals.
5. Contact local law enforcement in cases involving active sale or distribution of counterfeit controlled substances.
6. Seek immediate medical care if adverse effects are suspected following ingestion of any unverified medication. Inform emergency personnel of the suspected counterfeit exposure. Administer naloxone (Narcan) immediately if opioid overdose is suspected—fentanyl-adulterated products may require multiple naloxone doses. Call 911.

Public Health Resources: Quick-Reference Guide

FAQ: Akorn Codeine Oral Solution

Why was Akorn Codeine Oral Solution discontinued?

Akorn Codeine Oral Solution was permanently discontinued after Akorn Operating Company LLC filed for Chapter 7 bankruptcy on February 23, 2023. Manufacturing ended permanently, and all eligible within-expiry products were recalled because the company could no longer maintain FDA-required CGMP compliance and quality assurance systems.

Is Akorn Pharmaceuticals out of business?

Yes. Akorn Operating Company LLC permanently ceased all manufacturing and distribution following its Chapter 7 bankruptcy filing on February 23, 2023. The company no longer exists as an operational pharmaceutical manufacturer. No legitimate Akorn-branded medications are currently being produced or legally distributed.

Was Akorn Codeine Oral Solution recalled?

Yes. The FDA announced a voluntary consumer-level recall of all eligible within-expiry Akorn human drug products on May 4, 2023, including codeine oral solution formulations. The recall was necessitated by Akorn’s permanent closure and loss of required pharmaceutical quality assurance infrastructure.

Is Akorn Codeine Oral Solution still available?

No. Genuine Akorn Codeine Oral Solution is no longer legally manufactured or distributed in the United States. Any product newly offered under the Akorn brand is definitionally counterfeit and should be reported immediately to FDA MedWatch at 1-800-FDA-1088.

Is Akorn Codeine Oral Solution available online?

No legitimate Akorn codeine oral solution is available online or through any other channel. Akorn ceased manufacturing in February 2023. Any online source claiming to sell new Akorn-branded codeine syrup is operating illegally and selling a counterfeit product. Purchasing prescription controlled substances online without a valid prescription from an unverified source is a federal crime. Report suspected illegal online pharmacies to the NABP and FDA MedWatch.

Can old Akorn medication still be used?

Patients should not continue using recalled Akorn medication without first consulting their pharmacist or prescribing clinician. Quality conformance—including potency, stability, and freedom from contamination—can no longer be verified for any Akorn product. Consult a licensed healthcare professional before making any decisions about continued use or disposal.

Can counterfeit codeine syrup contain fentanyl?

Yes. Laboratory analyses of counterfeit opioid liquid products have confirmed the presence of fentanyl and nitazene-class synthetic opioids. Fentanyl is 50–100 times more potent than morphine by weight and can cause fatal respiratory depression in amounts imperceptible to the consumer. Nitazenes may not be reliably reversed by standard naloxone doses. Any unverified codeine syrup product must be treated as potentially fentanyl-adulterated.

How can someone identify counterfeit Akorn codeine syrup?

Because Akorn no longer manufactures any products, any newly produced Akorn-branded medication is counterfeit. Warning signs include products offered without a valid prescription via social media, messaging applications, or unverified websites; packaging inconsistencies including blurry print, spelling errors, or missing lot numbers; compromised tamper-evident seals; and transactions occurring outside licensed pharmacy channels.

What are the risks of counterfeit Akorn codeine syrup?

Counterfeit products may contain fentanyl, nitazenes, incorrect active ingredient concentrations, or unidentified adulterants. A single exposure can cause fatal respiratory depression. Risk is compounded when users apply historical dosing experience with legitimate codeine syrup to counterfeit products with an entirely different pharmacological profile.

What are the alternatives to Akorn Codeine Oral Solution?

Healthcare providers may prescribe FDA-approved generic codeine oral solutions from active manufacturers including Padagis and Pharmaceutical Associates Inc. Non-opioid antitussive alternatives including dextromethorphan, guaifenesin, and benzonatate may be appropriate depending on clinical indication. All medication transitions involving controlled substances require supervision by a licensed healthcare professional.

What should someone do with an old bottle of Akorn medication?

Do not continue using recalled Akorn medication without consulting a pharmacist or licensed healthcare provider. Dispose of the product through an authorized DEA drug take-back program, a designated collection site, or in accordance with FDA flush list guidance if take-back options are unavailable. Do not transfer, sell, or give the medication to any other person.

How can patients verify a legitimate generic manufacturer?

Patients can verify FDA-approved generic codeine manufacturers through the FDA Orange Book, which lists all approved drug products with manufacturer information. Prescriptions should only be filled at pharmacies verifiable through the NABP directory or a state board of pharmacy license check.

What is FDA MedWatch?

FDA MedWatch is the FDA’s official safety information and adverse event reporting program. It allows healthcare professionals and consumers to report serious problems—including suspected counterfeit medications, adverse drug reactions, and product quality concerns—directly to the FDA. Reports can be submitted online at FDA.gov/MedWatch or by calling 1-800-FDA-1088.

What should pharmacists do if a counterfeit medication is suspected?

Pharmacists who suspect a counterfeit product should immediately quarantine the product, document the chain of custody, report to FDA MedWatch at 1-800-FDA-1088, contact the FDA Office of Criminal Investigations, notify the DEA Diversion Control Division if the product is a controlled substance, alert their state board of pharmacy, and follow institutional protocols for handling potentially adulterated drug products.

Important Safety Disclaimer

Codeine oral solution is a federally controlled substance. It is legal only when prescribed by a licensed healthcare provider and dispensed by a licensed pharmacy for a documented clinical indication. Obtaining, possessing, selling, or transferring codeine-containing medication without a valid prescription constitutes a federal violation of the Controlled Substances Act and carries significant criminal penalties.

Akorn Operating Company LLC no longer exists as a pharmaceutical manufacturer. No legitimate Akorn-branded prescription medication is currently being manufactured or legally distributed anywhere in the United States. Any Akorn-branded product encountered in the current marketplace is counterfeit. Do not purchase, use, or distribute suspected counterfeit medications.

In many states, prescribers are required to consult the state Prescription Drug Monitoring Program (PDMP) before prescribing Schedule II–V controlled substances.

If you or someone you know is struggling with opioid use, contact the SAMHSA National Helpline at 1-800-662-4357 (free, confidential, 24/7) or visit findtreatment.gov. If opioid overdose is suspected, call 911 immediately and administer naloxone (Narcan) if available. Fentanyl-adulterated products may require multiple naloxone doses.

This article is provided for educational and public safety purposes only. It does not constitute medical, legal, or pharmaceutical advice. All clinical decisions regarding medication alternatives, disposal, or reporting obligations should be made in direct consultation with a licensed healthcare professional, pharmacist, or relevant regulatory authority.

Sources and References

• FDA Recall — Akorn Operating Company LLC (May 4, 2023)
• FDA MedWatch Safety Reporting Program
• FDA Drug Safety Communication — Codeine Restrictions (2017)
• FDA Drug Shortages Database
• FDA Orange Book — Approved Drug Products
• FDA Drug Disposal Guidance
• FDA Office of Criminal Investigations
• FDA Establishment Registration & Drug Listing
• DailyMed — NLM Drug Label Database
• RxNorm — NLM Drug Nomenclature
• United States Pharmacopeia (USP)
• DEA Drug Take-Back Program
• DEA Diversion Control Division
• DEA — Fentanyl Awareness Resources
• DEA Drug Scheduling Information
• CDC — Drug Overdose Prevention
• CDC — Prescription Drug Monitoring Program
• SAMHSA National Helpline — 1-800-662-4357
• NABP — .pharmacy Verified Program
• Controlled Substances Act — DEA Scheduling

Conclusion

The permanent closure of Akorn Operating Company LLC and the FDA’s May 2023 recall mark a consequential inflection point in the availability of generic codeine oral solutions in the United States. What began as a corporate bankruptcy has produced a multidimensional public health crisis: a disrupted pharmaceutical supply chain, a patient population requiring alternative sourcing, and an actively exploited brand name enabling a dangerous and growing counterfeit market.

The most urgent public health message arising from Akorn’s collapse is unambiguous: no legitimate Akorn-branded codeine syrup is being manufactured today, and none has been since February 2023. Any product presented under that label is counterfeit. In a market saturated with fentanyl- and nitazene-adulterated opioid products—where a single counterfeit dose can be fatal and indistinguishable from a legitimate product by appearance alone—the exploitation of a trusted pharmaceutical brand name by criminal producers demands clear, sustained, and authoritative public communication.

The Akorn case also illustrates a structural vulnerability in the U.S. generic pharmaceutical supply chain that extends well beyond this single manufacturer. When a significant supplier exits a market constrained by DEA production quotas, limited manufacturer redundancy, and sustained demand pressure, the consequences cascade outward—reaching patients, prescribers, pharmacists, regulators, and, most critically, the individuals most vulnerable to the counterfeit products that predictably fill the void.

For patients who relied on Akorn’s formulations, the path forward runs exclusively through licensed healthcare providers, FDA-approved alternative manufacturers verified through the Orange Book and DailyMed, and NABP-verified pharmacy channels. For clinicians and pharmacists navigating the supply disruption, the FDA Drug Shortages Database remains the most authoritative real-time resource. For anyone who encounters a product claiming to be Akorn-branded: do not use it. Report it. Seek immediate care if exposed.