[pending] CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0153-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
The recalled product
- Product
- CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
- Brand
- CLOMIPRAMINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- a) Lot # E410157
- Exp Date: 12/2026
- Lot # E407176
- Exp Date: 08/2026
- Lot # E405845
- Exp Date: 06/2026
- Lot # E400943
- Exp Date: 01/2026 b)Lot # E410156
- Lot # E400942
- Exp Date: 01/2026 c) Lot # E410158
- Lot # E407128
- Lot # E405846
- Lot # E400944
- Exp Date: 01/2026
Distribution
Distributed nationwide across the United States.
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