Clomipramine 50 mg capsules recalled over nitrosamine above the intake limit
Zydus Pharmaceuticals is recalling clomiPRAMINE Hydrochloride Capsules USP 50 mg after N-Nitroso Desmethyl-Clomipramine was found above the FDA acceptable intake limit.
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: Scored 3 under the risk-of-harm criterion: a named nitrosamine impurity above the FDA acceptable intake limit is a defined safety threshold breach, with no injuries reported.
Plain-English summary
ClomiPRAMINE Hydrochloride Capsules, USP, 50 mg, in 30-count (NDC 16714-850-01), 90-count (NDC 16714-850-02) and 100-count (NDC 16714-850-03) bottles, manufactured for Northstar Rx of Memphis, Tennessee, are being recalled for cGMP deviations.
An out of specification result was observed for nitrosamine drug substance-related impurities (NDSRIs), specifically N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Affected lots include E410157 (expiring December 2026), E407176 (expiring August 2026) and E405845 (expiring June 2026). The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Clomipramine is a prescription medicine, so patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
- Brand
- CLOMIPRAMINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Antidepressant
- Hazard
- nitrosamine
- impurity
- cgmp-deviation
- out-of-specification
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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