Class II · ModerateActive recall
Clomipramine Hydrochloride
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera) Lot # E403069, Exp Date: 04/2026; Lot # E406504, Exp Date: 07/2026; Lot # E309177, Exp Date: 11/2025; Lot # E400262, Exp Date: 12/2025; Lot # E404200, Exp Date: 05/2026 b) Lot # E403070, Exp Date: 04/2026; Lot # E406505, Exp Date: 07/2026; Lot # E407631, Exp Date: 08/2026; Lot # E400263, Exp Date: 12/2025; Lot # E404202, Exp Date: 05/2026 c) Lot # E403071, Exp Date: 04/2026; Lot # E407632, Exp Date: 08/2026; Lot # E405848, E405284, Exp Date: 07/2026; Lot # E400264, Exp Date: 12/2025; Lot # E404201, Exp Date: 05/2026
Where it was soldNationwide in the US
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byZydus Lifesciences Ltd., Ahmedabad, India foreign manufacturer
| Brand name | CLOMIPRAMINE HYDROCHLORIDE |
| Generic name | CLOMIPRAMINE HYDROCHLORIDE |
| Active ingredient(s) | CLOMIPRAMINE HYDROCHLORIDE |
| Distributed by / for | Northstar Rx LLC, Memphis, TN 38141 |
| NDC | 16714-851-01 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Distribution | Nationwide in the US |
| Quantity | N/A |
| Recall initiated | 2025-10-22 |
| Report date | 2025-11-12 |
| Recall completed | — |
| Recall number | D-0154-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Pennington NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.