FDA Drugs recall ·
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only… recall
- Recall number
- D-0541-2026
- Date
- (initiated April 24, 2026)
- Company / brand
- Lupin Pharmaceuticals Inc.
5801 Pelican Bay Blvd Ste 500, Naples, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 217,621 pen injectors
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.
Why was it recalled?
Presence of particulate matter: a white thread-like structure in the cartridge
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
Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2027; WB00104, WB00106, WB00105, Expires: Oct. 2027.
Distribution
Nationwide within U.S
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-0541-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.