Recalls / Class II
Class IID-0537-2025
Product
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, 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 # M300464, exp. date June, 2025
Why it was recalled
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
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
- 2,724 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2025-06-27
- FDA classified
- 2025-07-21
- Posted by FDA
- 2025-07-30
- Terminated
- 2026-01-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0537-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.