FDAClass II · Drug · Recalled May 27, 2026

Liraglutide Injection recall — Lupin Pharmaceuticals Inc.

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0541-2026
Brand: Lupin Pharmaceuticals
Classification: Class II
Units affected: 217,621 pen injectors
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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.

Affected products

Liraglutide Injection

Companies & origin

Recalling firm location: Naples, FL, United States
Firm address: 5801 Pelican Bay Blvd Ste 500, 34108-2734

Identifying details (verbatim from the notice)

Product codes / lots: 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
Firm notified the public via: Letter
FDA event ID: 98809
Recall initiated: April 24, 2026
FDA classified: May 19, 2026
FDA report date: May 27, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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