Reported Nov 12, 2025 · Ongoing
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), 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 16714-850-01) |
| 2 | 90-count bottles (NDC 16714-850-02) |
| 3 | 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India |
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 12/2026 2 Lot # E407176, Exp Date: 08/2026 3 Lot # E405845, Exp Date: 06/2026 4 Lot # E400943, Exp Date: 01/2026 b)Lot # E410156, Exp Date: 12/2026 5 Lot # E400942, Exp Date: 01/2026 c) Lot # E410158, Exp Date: 12/2026 6 Lot # E407128, Exp Date: 08/2026 7 Lot # E405846, Exp Date: 06/2026 8 Lot # E400944, Exp Date: 01/2026 - 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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