Chlorpromazine Hydrochloride Tablets — Class II drug recall D-0635-2025
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2025-09-17, distributed nationwide. CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
| Recall number | D-0635-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2025-09-03 |
| Classified | 2025-09-10 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 16714-0047, 16714-0047-01, 16714-0048, 16714-0048-01, 16714-0049, 16714-0049-01, 16714-0050, 16714-0050-01, 16714-0051, 16714-0051-01 |
| Lot numbers | Z306326, Z401155 |
Product
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
Reason for recall
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable 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-0635-2025. 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.