Class III
Terminated
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
- Recall Initiated
- November 5, 2024
- Posted
- November 20, 2024
- Recall Number
- D-0045-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 25814 tablets
- Firm Location
- La Vergne, TN, United States
Reason for Recall
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Distribution
Nationwide in the US.
Lot / Code Info
Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
More recalls by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only...
Oct 15, 2025 · Class II
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blist...
Sep 17, 2025 · Class II
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by...
Aug 27, 2025 · Class II
Other recent Class III Drug recalls
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Via...
Slate Run Pharmaceuticals
· Mar 4, 2026
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceutica...
Unichem Pharmaceuticals Usa Inc.
· Feb 18, 2026
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL),...
Haleon Us Holdings Llc
· Feb 4, 2026
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceutic...
Novadoz Pharmaceuticals Llc
· Feb 4, 2026
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd.,...
Cipla Usa, Inc.
· Jan 28, 2026