US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

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

PAPAVERINE HYDROCHLORIDE Injection

Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Vitae Enim Vitae Scientific, Inc. NDC 72516-024-25 D-0742-2022
Class II · Moderate risk Terminated

TETRACAINE 1% Tetracaine HCI Injection

Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Vitae Enim Vitae Scientific, Inc. NDC 42494-437-10 D-0741-2022
Class II · Moderate risk Terminated

Sucralfate Oral Suspension

Reason Labeling: Label Mix-Up

DASH Pharmaceuticals LLC NDC 69339-148-17 D-0749-2022
Class II · Moderate risk Terminated

Rock Town - Distillery - Hand Sanitizer

Reason CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.

Rock Town Distillery, Inc. NDC 74492-0002-1 D-0715-2022
Class II · Moderate risk Terminated

NAD+ Nicotinamide Adenine Dinucleotide

Reason Product found to be Sub Potent or Exceeded reconstitution time

Olympia Compounding Pharmacy dba Olympia Pharmacy D-0719-2022
Class II · Moderate risk Terminated

Alprazolam C-IV 2 mg

Reason CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)

Direct Rx NDC 72189-0058-60 D-0651-2022
Class II · Moderate risk Terminated

Alprazolam C-IV 1 mg 60-count bottles

Reason CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)

Direct Rx NDC 61919-836-60 D-0650-2022
Class II · Moderate risk Terminated

HAND SANITIZER Isopropyl Alcohol Antiseptic 75%

Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Tennessee Technical Coatings, Corp. NDC 76921-000-01 D-0740-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.

Golden State Medical Supply Inc. NDC 60429-504-18 D-0654-2022
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 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