ChlorproMAZINE Hydrochloride Tablets — Class II drug recall D-0366-2025
Ongoing recall by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, reported 2025-04-23, distributed nationwide. CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
| Recall number | D-0366-2025 |
|---|---|
| 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 | 2025-04-14 |
| Classified | 2025-04-16 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 133 cartons |
| Reason classes | cgmp, specification failure |
| NDC | 00904-7129-61 |
| Lot numbers | N02114 |
| Expiration dates | 2025-12-31 |
Product
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
Reason for recall
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim 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-0366-2025. 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.