clomiPRAMINE Hydrochloride — Class II drug recall D-0154-2026
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2025-11-12, distributed nationwide. cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N
| Recall number | D-0154-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2025-10-22 |
| Classified | 2025-11-04 |
| Reported by FDA | 2025-11-12 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 16714-0849, 16714-0849-01, 16714-0849-02, 16714-0849-03, 16714-0850, 16714-0850-01, 16714-0850-02, 16714-0850-03, 16714-0851, 16714-0851-01, 16714-0851-02, 16714-0851-03 |
| Lot numbers | E309177, E400262, E400263, E400264, E403069, E403070, E403071, E404200, E404201, E404202, E405284, E405848, E406504, E406505, E407631, E407632 |
| Expiration dates | 2025-11, 2025-12, 2026-04, 2026-05, 2026-07, 2026-08 |
Product
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.
Reason for recall
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA 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-0154-2026. 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.