Clomipramine 25 mg capsules recalled over nitrosamine above the intake limit
Zydus Pharmaceuticals is recalling clomiPRAMINE Hydrochloride Capsules USP 25 mg after N-Nitroso Desmethyl-Clomipramine was found above the FDA acceptable intake limit.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, 25 mg, in 30-count (NDC 16714-849-01), 90-count (NDC 16714-849-02) and 100-count (NDC 16714-849-03) 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 E408871 (expiring October 2026), E405282 (expiring June 2026) and E400386 (which expired December 2025). 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
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 (11)
- a) Lot # E408871
- Exp Date: 10/2026
- Lot # E405282
- Exp Date: 06/2026
- Lot # E400386
- Exp Date: 12/2025 b) Lot # E408872
- Lot # E405280
- Exp Date: 06/2026 c) Lot # E408873
- Lot # E405281
- Lot # E400387
- Exp Date: 12/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Zydus Pharmaceuticals (USA) Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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