FDA Drugs recall ·
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles… recall
- Recall number
- D-0537-2025
- Date
- (initiated June 27, 2025)
- Company / brand
- Lupin Pharmaceuticals Inc.
5801 Pelican Bay Blvd, Naples, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 2,724 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # M300464, exp. date June, 2025
Distribution
Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0537-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.