Recalls / Class II
Class IID-0377-2025
Product
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
- Brand name
- Clomipramine Hydrochloride
- Generic name
- Clomipramine Hydrochloride Capsules
- Active ingredient
- Clomipramine Hydrochloride
- Route
- Oral
- NDCs
- 68180-492, 68180-493, 68180-494
- FDA application
- ANDA209294
- Affected lot / code info
- Lot #: M300442, Exp Date: 6/30/2025
Why it was recalled
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5801 Pelican Bay Blvd, Suite 500, Naples, Florida 34108-2755
Distribution
- Quantity
- 2724 bottles
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2025-04-10
- FDA classified
- 2025-04-18
- Posted by FDA
- 2025-04-30
- Terminated
- 2026-01-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0377-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.