D-0541-2026 Class II Ongoing

Recalled by Lupin Pharmaceuticals Inc. — Naples, FL

Recall Details

Product Type
Drugs
Report Date
May 27, 2026
Initiation Date
April 24, 2026
Termination Date
N/A
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.