← FDA ENFORCEMENT
D-0541-2026Class II

Lupin Pharmaceuticals Inc.

Recalling firm
Lupin Pharmaceuticals Inc.
Product type
Drug
Status
Ongoing
Report date
2026-05-27
Distribution
Nationwide within U.S
Firm state
FL
Product quantity
217,621 pen injectors
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of particulate matter: a white thread-like structure in the cartridge

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.

Code / lot info

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.

Other recalls SPEQ maps to Environmental Monitoring
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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.