Home / Recalls / The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / D-0045-2025

D-0045-2025 Class III Terminated

Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — La Vergne, TN

Recall Details

Product Type
Drugs
Report Date
November 20, 2024
Initiation Date
November 5, 2024
Termination Date
September 16, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25814 tablets

Product Description

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.

Reason for Recall

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

Distribution Pattern

Nationwide in the US.

Code Information

Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025

Other recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

  • D-0012-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) bli (September 12, 2025)
  • D-0013-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) bli (September 12, 2025)
  • D-0010-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blis (September 12, 2025)
  • D-0009-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) bliste (September 12, 2025)
  • D-0011-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) bli (September 12, 2025)
  • D-0625-2025 Class II — Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Table (September 2, 2025)
  • D-0624-2025 Class II — Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tabl (September 2, 2025)
  • D-0594-2025 Class II — Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Package (August 20, 2025)
  • D-0366-2025 Class II — ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TAB (April 14, 2025)
  • D-0304-2025 Class III — Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit (March 4, 2025)