chlorproMAZINE Hydrochloride Tablets — Class II drug recall D-0309-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-04-09, distributed nationwide. CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
| Recall number | D-0309-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2025-03-11 |
| Classified | 2025-04-02 |
| Reported by FDA | 2025-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 8,160 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 68462-0861, 68462-0861-01, 68462-0861-10, 68462-0862, 68462-0862-01, 68462-0862-10, 68462-0863, 68462-0863-01, 68462-0863-10, 68462-0864, 68462-0864-01, 68462-0864-10, 68462-0865, 68462-0865-01, 68462-0865-10 |
| Lot numbers | 17232222, 17232237 |
| Expiration dates | 2025-10-31 |
Product
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
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-0309-2025. 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.