FDA Drug Recalls

14,801 recalls, newest first

Class I · High risk Terminated Feb 12, 2024

ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.

Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the…

FA Online Inc D-0470-2024

Class II · Moderate risk Terminated Feb 12, 2024

CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or…

Reason CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment…

Mckesson Corporation NDC 0187-0006-25 D-0347-2024

Class II · Moderate risk Terminated Feb 9, 2024

Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA…

Reason Failed Stability Specifications: Out of specification for blend uniformity.

Micro Labs Limited NDC 42571-227-30 D-0388-2024

Class III · Low risk Terminated Feb 9, 2024

Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx…

Reason Failed Dissolution Specifications: results slightly under spec at at 9-months.

Stason Pharmaceuticals, Inc. NDC 69076-913-02 D-0367-2024

Class II · Moderate risk Terminated Feb 9, 2024

HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for…

Reason an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-6440-61 D-0324-2024

Class II · Moderate risk Terminated Feb 7, 2024

Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals…

Reason cGMP Deviations: Products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 60793-0701-10 D-0373-2024

Class II · Moderate risk Terminated Feb 7, 2024

Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01

Reason cGMP Deviations: Products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 54643-5649-01 D-0372-2024

Class II · Moderate risk Terminated Feb 7, 2024

Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC…

Reason cGMP Deviations: Products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 55150-226-10 D-0371-2024

Class I · High risk Terminated Feb 5, 2024

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue…

Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Super Chill Products D-0393-2024

Class II · Moderate risk Terminated Feb 5, 2024

Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to…

Reason Labeling: Incorrect or Missing Package Insert

Lupin Pharmaceuticals Inc. D-0337-2024

Class II · Moderate risk Terminated Feb 1, 2024

Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India…

Reason CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking…

NATCO Pharma Limited NDC 16571-742-41 D-0318-2024

Class II · Moderate risk Terminated Jan 25, 2024

Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park…

Reason CGMP Deviations

Alpha Aromatics D-0338-2024

Class II · Moderate risk Terminated Jan 25, 2024