Reported Nov 12, 2025 · Ongoing
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count…
Zydus Pharmaceuticals (USA) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 30-count bottles (NDC 16714-849-01) |
| 2 | 90-count bottles (NDC 16714-849-02) |
| 3 | 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India |
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 10/2026 2 Lot # E405282, Exp Date: 06/2026 3 Lot # E400386, Exp Date: 12/2025 b) Lot # E408872, Exp Date: 10/2026 4 Lot # E405280, Exp Date: 06/2026 c) Lot # E408873, Exp Date: 10/2026 5 Lot # E405281, Exp Date: 06/2026 6 Lot # E400387, Exp Date: 12/2025 - Amount recalled
- N/A
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
This product could cause temporary or reversible health problems — stop using it.
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