FDA recall D-0541-2026

Product

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

Nationwide within U.S

Key facts

Status

Ongoing

Initiation date

2026-04-24

Report date

2026-05-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0541-2026