D-0541-2026 Class II Ongoing
FDA drug recall D-0541-2026 was initiated by Lupin Pharmaceuticals Inc. on Apr 24, 2026 and is designated Class II. Reason for recall: Presence of particulate matter: a white thread-like structure in the cartridge The recall status is ongoing. Affected quantity: 217,621 pen injectors.
Recall Details
- Product Type
- Drugs
- Report Date
- May 27, 2026
- Initiation Date
- Apr 24, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 217,621 pen injectors
Product Description
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.
Reason for Recall
Presence of particulate matter: a white thread-like structure in the cartridge
Distribution Pattern
Nationwide within U.S
Code Information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0541-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026