Home / Recalls / The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / D-0012-2026

D-0012-2026 Class II Ongoing

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

Recall Details

Product Type
Drugs
Report Date
October 15, 2025
Initiation Date
September 12, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
866 blister packs

Product Description

Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614

Reason for Recall

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Distribution Pattern

Nationwide

Code Information

Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026

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

  • D-0009-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) bliste (September 12, 2025)
  • D-0010-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blis (September 12, 2025)
  • D-0011-2026 Class II — Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 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-0624-2025 Class II — Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tabl (September 2, 2025)
  • D-0625-2025 Class II — Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Table (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)
  • D-0221-2025 Class II — Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets p (January 30, 2025)