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.
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, 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
Same brand · CLOMIPRAMINE HYDROCHLORIDE
- HighClomipramine 75 mg capsules recalled over nitrosamine above the intake limit
FDA (Drugs) · 2025-11-12
- HighClomipramine 50 mg capsules recalled over nitrosamine above the intake limit
FDA (Drugs) · 2025-11-12
- ModerateClomipramine capsules failed a degradation product specification at expiry testing
FDA (Drugs) · 2025-07-30
- ModerateClomipramine Hydrochloride Capsules recalled for degradation product specification failure
FDA (Drugs) · 2025-04-30
- HighAntidepressant Medication Recalled for Excessive Active Ingredient Potency
FDA (Drugs) · 2022-10-05
Same manufacturer · Zydus Pharmaceuticals (USA) Inc
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- SevereErythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- HighIcosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18
- HighIcosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28
Same hazard · nitrosamine
See all →- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
FDA (Drugs) · 2026-02-11
- HighUnit dose prazosin 1 mg cartons recalled over nitrosamine impurity
FDA (Drugs) · 2025-11-05