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.
Product description
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Lot numbers, UPCs & expiration codes
Lot # M300464, exp. date June, 2025
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0537-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 27, 2025
- FDA report date
- Jul 30, 2025
- Quantity
- 2,724 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0537-2025, exactly as published.
Show all FDA fields
- City
- Naples
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 97159
- Address
- 5801 Pelican Bay Blvd
- Address (line 2)
- Suite 500
- Code information
- Lot # M300464, exp. date June, 2025
- Postal code
- 34108-2755
- Report date
- Jul 30, 2025
- Product type
- Drugs
- Recall number
- D-0537-2025
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 2,724 bottles
- Termination date
- Jan 5, 2026
- Reason for recall
- Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jun 27, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 21, 2025