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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Akorn Pharmaceuticals Recalled Due to Facility Closure and Quality Issues

Agency Publication Date: June 2, 2023
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Summary

Akorn, Inc. is recalling all lots of various prescription and over-the-counter medications because the company has ceased operations and can no longer continue required quality and stability testing. This recall involves dozens of products including Sufenta (sufentanil citrate), Timolol Maleate eye drops, and various oral suspensions distributed under the Akorn, Hi-Tech Pharmacal, and VersaPharm brands. Because the firm can no longer guarantee that these medications maintain their strength and purity through their expiration dates, they may not work as intended or could pose health risks.

Risk

The manufacturer cannot ensure the drugs will remain stable and effective because all quality testing was stopped when the company went out of business. This lack of oversight means medications might lose potency or degrade before they are used, which could lead to treatment failure.

What You Should Do

  1. This recall affects dozens of medications labeled under the Akorn, Akorn Operating Company, VersaPharm, and Hi-Tech Pharmacal brands, including all lots and all package sizes.
  2. Identify your medication by checking the manufacturer or distributor information on the bottle or carton label for Akorn, Inc., Akorn Operating Company LLC, Hi-Tech Pharmacal Co., Inc., or VersaPharm, Inc.
  3. See the Affected Products section below for the full list of affected codes, as this recall covers over 70 distinct medications including injectable, oral, and ophthalmic (eye) solutions.
  4. If you have health concerns related to any of these medications, contact your healthcare provider or pharmacist immediately for guidance on alternatives.
  5. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

💰Option 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
🗑️Option 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sufenta (Sufentanil Citrate Injection, USP)
Variants: 50 mcg/mL, 1 mL ampules, 2 mL ampules, 5 mL ampules
Lot Numbers:
All Lots

ALL NDCs; For Intravenous and Epidural Use; Rx only

Product: Sulfamethoxazole & Trimethoprim Oral Suspension USP
Variants: 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Timolol Maleate Ophthalmic Solution, USP 0.5%
Variants: 2.5 mL bottles, 5 mL bottles, 10 mL bottles, 15 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Tobramycin Inhalation Solution USP
Variants: 300 mg/5 mL, 4 single-dose ampules
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Tobramycin Ophthalmic Solution, USP 0.3%
Variants: 5 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Trihexyphenidyl Hydrochloride Oral Solution, USP
Variants: 2mg/5mL, 473 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Distributed by VersaPharm, Inc.; Rx only

Product: Tropicamide Ophthalmic Solution, USP 0.5%
Variants: 15 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Valproic Acid Oral Solution, USP
Variants: 250mg/5mL, 473 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Vitamin D Supplement Drops
Variants: 400 IU, Cherry Flavored, 50mL bottle
Lot Numbers:
All Lots

ALL NDCs

Product: XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate
Variants: 1.25mg/3mL, 0.5 mL unit-dose vials
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Amantadine Hydrochloride Oral Solution USP
Variants: 50mg/5mL, 473mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Calcitriol Injection
Variants: 2 mcg/mL, 1 mL ampules
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Midazolam Injection, USP
Variants: 50 mg/10mL (5mg/mL), 10 mL vials
Lot Numbers:
All Lots

ALL NDCs; Rx only; For Intramuscular or Intravenous Use Only

Product: Olopatadine HCl Ophthalmic Solution, USP 0.2%
Variants: 5mL bottles, Sterile
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%
Variants: 15 mL bottles, Sterile
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%
Variants: 15 mL bottles, Sterile
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Ropivacaine Hydrochloride Injection USP 0.2%
Variants: 200mg/100 mL (2 mg/mL), 100 mL Vial
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Tropicamide Ophthalmic Solution, USP 0.1%
Variants: 15 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Rifampin Capsules USP 300 mg
Variants: 30 count bottles, 60 count bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Ropivacaine Hydrochloride Injection USP 0.5%
Variants: 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Acetaminophen & Codeine Phosphate Oral Solution
Variants: 120mg/12mg/5mL, 473mL bottles, 40 UD cups
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Acetic Acid Otic Solution
Variants: 15 mL bottle
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Acyclovir Oral Suspension
Variants: 200mg/5mL
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Fentanyl Citrate Injection, USP
Variants: 100 mcg/2mL (50 mcg/mL)
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Sodium Chloride Ophthalmic Ointment, USP 5%
Variants: 3.5g tubes
Lot Numbers:
All Lots

ALL NDCs

Product: Sodium Chloride Ophthalmic Solution, USP 5%
Variants: 50mg/mL, 15 mL bottles
Lot Numbers:
All Lots

ALL NDCs

Product: Albuterol Sulfate Syrup
Variants: 2mg (base), 16 fl oz (473 mL)
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Sodium DIURIL (chlorothiazide sodium)
Variants: 0.5g/vial, Single-dose vial
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Apraclonidine Ophthalmic Solution 0.5%
Variants: 5mL bottles, 10 mL bottles, Sterile
Lot Numbers:
All Lots

ALL NDCs; For Topical Ophthalmic Use Only; Rx only

Product: Artificial Tears Solution
Variants: Polyvinyl Alcohol 1.4%, Ophthalmic Use
Lot Numbers:
All Lots

ALL NDCs

Product: Artificial Tears Ointment
Variants: Sterile, 3.5 gram tubes
Lot Numbers:
All Lots

ALL NDCs

Product: Azelastine Hydrochloride Nasal Spray 0.15%
Variants: 105.5 mcg per spray
Lot Numbers:
All Lots

ALL NDCs; Manufactured by Hi-Tech Pharmacal Co., INC.; Rx only

Product: AK-POLY-BAC Ophthalmic Ointment
Variants: 3.5g, Sterile
Lot Numbers:
All Lots

ALL NDCs; Contains Bacitracin Zinc and Polymyxin B Sulfate; Rx only

Product: Calcipotriene Topical Solution 0.005%
Variants: Scalp Solution, 60 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Calcitriol Injection
Variants: 1 mcg/mL, 1 mL ampules
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Levofloxacin Oral Solution 25 mg/mL
Variants: 100 mL bottles, 200 mL bottles, 480 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Levofloxacin Ophthalmic Solution 0.5%
Variants: 5 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Lidocaine 2.5% & Prilocaine 2.5% Cream
Variants: 30 gram tubes
Lot Numbers:
All Lots

ALL NDCs; Rx only; Manufactured by Hi-Tech Pharmacal Co., INC.

Product: Lidocaine Ointment USP 5%
Variants: 1 1/4 oz tubes
Lot Numbers:
All Lots

ALL NDCs; Rx only; Manufactured for Hi-Tech Pharmacal Co., INC.

Product: Lidocaine HCl Jelly USP 2%
Variants: 5mL tubes
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%
Variants: 100mL tubes
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Lorazepam Injection, USP 2 mg/mL
Variants: 1 mL vials, Sterile
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Lorazepam Oral Concentrate, USP 2mg per mL
Variants: 30 mL bottles, Sterile
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Megestrol Acetate Oral Suspension, USP 40 mg/mL
Variants: 240 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Midazolam Injection, USP 2mg/2mL (1 mg/mL)
Variants: 2mL vials
Lot Numbers:
All Lots

ALL NDCs; For Intramuscular or Intravenous Use Only; Rx only

Product: Moxifloxacin HCl Ophthalmic Solution, USP 0.5%
Variants: 3 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Naloxone Injection, USP 0.4 mg/mL
Variants: 1 mL vials
Lot Numbers:
All Lots

ALL NDCs; For Intravenous, Intramuscular or Subcutaneous Use; Rx only

Product: Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment
Variants: 3.5 g tubes
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Olopatadine HCl Nasal Spray 665 mcg
Variants: 30.5 g bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Olopatadine HCl Ophthalmic Solution, USP 0.1%
Variants: 5 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Oxcarbazepine Oral Suspension, USP 300 mg/5 mL
Variants: 250 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%
Variants: 15 mL bottles, Sterile
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Prednisolone Oral Solution, USP 15 mg/5 mL
Variants: 240 mL bottles, 480 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Promethazine HCl & Codeine Phosphate Oral Solution, USP
Variants: 6.25mg/10mg per 5 mL
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Promethazine HCl Oral Solution, USP 6.25 mg/5mL
Variants: 473 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Proparacaine HCl Ophthalmic Solution, USP 0.5%
Variants: 15 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Rifampin Capsules USP 150 mg
Variants: 30-count bottles, Sterile
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Atropine Sulfate Ophthalmic Solution, USP 1%
Variants: 2 mL bottles, 5 mL bottles, 15 mL bottles, Sterile
Lot Numbers:
All Lots

ALL NDCs; For Topical Application To The Eye; Rx only

Product: Cetrorelix Acetate for Injection 0.25 mg
Variants: Sterile, Lyophilized powder
Lot Numbers:
All Lots

ALL NDCs; Manufactured by GP Pharm S.A. Barcelona, Spain; For subcutaneous use only; Rx only

Product: Ciclopirox Topical Solution 8% (Nail Lacquer)
Variants: 6.6 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Cimetidine HCl Oral Solution 300mg/5mL
Variants: 237 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Clobetasol Propionate Cream, USP 0.05%
Variants: 15g tubes, 30g tubes, 60g tubes
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Clobetasol Propionate Ointment, USP 0.05%
Variants: 15 g tubes
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Clobetasol Propionate Shampoo 0.05%
Variants: 4oz (118 mL) bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Cromolyn Sodium Ophthalmic Solution, USP 4%
Variants: 10 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: DetomiSed (detomidine hydrochloride)
Variants: 5mL vials, 20mL vials
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Dicyclomine Hydrochloride Injection USP
Variants: 20 mg/2 mL (10 mg/mL), 2 mL ampules
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Diuril (chlorothiazide sodium) Injection
Variants: 500mg/vial, Single-Dose Vial
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: DOCU LIQUID (docusate sodium)
Variants: 50 mg/5 mL, 473mL bottles, 10mL Unit Dose cups
Lot Numbers:
All Lots

ALL NDCs

Product: Ephedrine Sulfate Injection, USP
Variants: 50 mg/mL, 1mL Single Dose Ampules
Lot Numbers:
All Lots

ALL NDCs; For Intravenous Use; Rx only

Product: Ferrous Sulfate Iron Supplement Drops
Variants: 50 mL bottles
Lot Numbers:
All Lots

ALL NDCs

Product: Fluticasone Propionate Nasal Spray
Variants: 50mcg, 16 g bottles
Lot Numbers:
All Lots

ALL NDCs; Manufactured by Hi-Tech Pharmacal Co., INC.

Product: Gonak Hypromellose Ophthalmic Solution 25mg/mL
Variants: 15 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Granisetron HCl Injection, USP 1 mg/mL
Variants: 1mL vials, 4 mL vials
Lot Numbers:
All Lots

ALL NDCs; For Intravenous Use Only; Rx only

Product: Guaiatussin AC Sugar-Free
Variants: Guaifenesin 100 mg, Codeine Phosphate 10 mg, 118 mL bottles, 473 mL bottles, 100 unit dose cups
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Guaifenesin Oral Solution 300 mg/ 15 mL
Variants: Sugar Free, Alcohol Free
Lot Numbers:
All Lots

ALL NDCs; For Institutional Use Only; Rx only

Product: HydrALAZINE HCl Injection, USP 20 mg/mL
Variants: 1 mL Single Dose vials
Lot Numbers:
All Lots

ALL NDCs; For Intramuscular or Intravenous Use; Rx only

Product: Hydrocortisone and Acetic Acid Otic Solution, USP
Variants: 10 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Hydromorphone Hydrochloride Injection, USP
Variants: 50mg/5mL (10 mg/mL), 1 mL ampules, 5 mL ampules, 50 mL vials, Sterile
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit
Variants: Sterile
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Ketorolac Tromethamine Ophthalmic Solution 0.5%
Variants: Sterile, 3mL bottles, 5 mL bottles, 10 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Lactulose Solution, USP (Oral) 10g/15 mL
Variants: 15mL bottles, 30 mL bottles, 473 mL bottles, 946 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Lactulose Solution, USP (Oral/Rectal) 30 mL
Variants: Unit Dose Cups
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Levetiracetam Oral Solution 100 mg/mL
Variants: 473 mL
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Levocarnitine Oral Solution, USP
Variants: 118 mL bottles
Lot Numbers:
All Lots

ALL NDCs; Rx only

Product: Levofloxacin Injection 500mg/20 mL (25 mg/mL)
Variants: 20mL vials, 30 mL vials
Lot Numbers:
All Lots

ALL NDCs; For Intravenous Infusion; Rx only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91788
Status: Active
Manufacturer: Akorn, Inc.
Sold By: Pharmacies; Hospitals; Clinics; Authorized Drug Distributors
Manufactured In: United States, Spain
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release (1) · FDA Press Release (2) · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.