Clomipramine Hydrochloride Capsules recalled for degradation product specification failure
Lupin Pharmaceuticals is recalling Clomipramine Hydrochloride Capsules (25 mg) due to an unspecified degradation product detected in stability testing. The defect was identified during an 18-month long-term stability study.
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: This is an FDA Class II recall involving a quality/stability defect (impurity/degradation product) with no reported illnesses, injuries, or adverse health effects documented in the source. The hazard is analytical/theoretical rather than immediate or reported.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Clomipramine Hydrochloride Capsules USP, 25 mg, in 100-count bottles (Lot #M300442, expiration 6/30/2025) distributed nationwide in the United States. The recall was initiated due to an out-of-specification result in a degradation product test during an 18-month long-term stability study, where an unspecified degradation product was detected.
Clomipramine hydrochloride is a tricyclic antidepressant used to treat obsessive-compulsive disorder and other conditions. The presence of unspecified degradation products may indicate that the product does not meet established quality standards.
Patients currently taking this medication should contact their healthcare provider or pharmacist before discontinuing use. Do not stop taking the medication without medical guidance. Return unused product to the pharmacy or dispose of it according to local instructions.
The recalled product
- Product
- CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)
- Brand
- CLOMIPRAMINE HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Hazard
- degradation-product
- impurity
- specification-failure
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 (2)
- Lot #: M300442
- Exp Date: 6/30/2025
UPCs (2)
- 0368180494065
- 0368180493068
Distribution
Distributed nationwide across the United States.
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