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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 2,521–2,540 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.