Major ChlorproMAZINE Hydrochloride Tablets — Class II drug recall D-0011-2026
Ongoing recall by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, reported 2025-10-15, distributed nationwide. CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
| Recall number | D-0011-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN, United States |
| Recall initiated | 2025-09-12 |
| Classified | 2025-10-07 |
| Reported by FDA | 2025-10-15 |
| Distributed | Nationwide (US) |
| Quantity | 506 blister |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00309047131617 |
| NDC | 00904-7131-61 |
| Lot numbers | N02009, N02026 |
| Expiration dates | 2026-02-28 |
Product
Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617
Reason for recall
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0011-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.