The nationwide Class II recall covers 217,621 pen injectors. The enforcement record gives the reason as presence of particulate matter, described as a white thread-like structure in the cartridge.
Silver Spring, Maryland, 27 May 2026 — The Food and Drug Administration enforcement file records an ongoing Class II recall initiated by Lupin Pharmaceuticals Inc. of Naples, Florida, on 24 April 2026 and classified on 19 May 2026.
The record covers 217,621 pen injectors of liraglutide injection, manufactured by Lupin Limited in Nagpur, India, and distributed nationwide within the United States. The recall is recorded as voluntary and firm-initiated, with customers notified by letter. The reason given on the record is presence of particulate matter: a white thread-like structure in the cartridge.
Source documents
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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.
- Identifier
- Recall number D-0541-2026
- As the record states
- Presence of particulate matter: a white thread-like structure in the cartridge
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Firm location
- Naples, FL, United States
- Classification
- Class II
- Status on the record
- Ongoing
- Quantity
- 217,621 pen injectors
- Distribution
- Nationwide within U.S
- Initiated
- 2026-04-24
- Classified
- 2026-05-19