US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

HEB 50% Isopropyl Alcohol First Aid Antiseptic

Reason Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.

Vi-Jon, Inc. D-0644-2022
Class III · Low risk Terminated

Clotrimazole and Betamethasone Dipropionate Cream USP

Reason Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

Taro Pharmaceuticals U.S.A., Inc. NDC 51672-4048-1 D-0727-2022
Class II · Moderate risk Terminated

0.9% Sodium Chloride Injection USP

Reason Lack of sterility assurance: leaking bags

B. Braun Medical, Inc. NDC 0264-7800-20 D-0655-2022
Class II · Moderate risk Terminated

hydrALAZINE HCl Tablets

Reason Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.

The Harvard Drug Group NDC 0904-6440-61 D-0653-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason CGMP deviations

Preferred Pharmaceuticals, Inc. D-0642-2022
Class II · Moderate risk Terminated

Dexamethasone Elixir

Reason Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

Morton Grove Pharmaceuticals, Inc. NDC 60432-466-08 D-0713-2022
Class II · Moderate risk Ongoing

All Over-The-Counter

Reason CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.

Dollar Tree Distribution, Inc. D-0641-2022
Class II · Moderate risk Terminated

Olanzapine Tablets

Reason cGmp Deviations

Macleods Pharma Usa Inc NDC 33342-070-07 D-0639-2022
Class II · Moderate risk Terminated

Pyrazinamide Tablets

Reason cGMP Deviations

ANI Pharmaceuticals, Inc. NDC 67253-660-10 D-0568-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason cGMP Deviations

ANI Pharmaceuticals, Inc. NDC 67253-903-10 D-0567-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason cGMP Deviations

ANI Pharmaceuticals, Inc. NDC 67253-902-10 D-0566-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason cGMP Deviations

ANI Pharmaceuticals, Inc. NDC 67253-901-10 D-0565-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason cGMP Deviations

ANI Pharmaceuticals, Inc. NDC 67253-900-10 D-0564-2022
Class I · High risk Terminated

Hcg 6

Reason Non-sterility; bacterial contamination identified as Paenibacillus lautus.

Revive Rx LLC dba Revive Rx Pharmacy D-0648-2022
Class I · High risk Terminated

RISE UP RED EDITION Capsules

Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Positive Health D-0645-2022
Class I · High risk Terminated

Avaphinal Maximum Male Enhancement Sexual Pills

Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Walmart Stores D-0725-2022