Clomipramine capsules failed a degradation product specification at expiry testing
Clomipramine Hydrochloride Capsules USP 25 mg are being recalled after an out of specification result for an unspecified degradation product during retention sample testing at expiry. 2,724 bottles affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for an out-of-specification degradation result found at expiry, with no named impurity or health consequence stated.
Plain-English summary
Clomipramine Hydrochloride Capsules USP, 25 mg, 100 count bottles, NDC 68180-492-01, are being recalled. The action covers 2,724 bottles.
The stated reason is failed impurities and degradation specifications: an out of specification result was observed in the degradation product test for any unspecified degradation product during retention sample testing at expiry. The FDA classified the action as Class II. The source does not name the degradation product or state a health consequence.
The affected lot is M300464, expiring June 2025. Distribution was nationwide.
Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the manufacturer.
The recalled product
- Product
- CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)
- Brand
- CLOMIPRAMINE HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral capsule
- Hazard
- degradation-product
- out-of-specification
- retention-testing
- class-ii
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 (3)
- Lot # M300464
- exp. date June
- 2025
UPCs (2)
- 0368180494065
- 0368180493068
Distribution
Distributed nationwide across the United States.
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