FDA Drugs recall ·
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only… recall
- Recall number
- D-0377-2025
- Date
- (initiated April 10, 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
- 2724 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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.
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 #: M300442, Exp Date: 6/30/2025
Distribution
USA 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-0377-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.