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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
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 23, 2026 at 11:04 PM UTC.
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