On April 24, 2026, Lupin Pharmaceuticals Inc. initiated a recall of Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only. The U.S. FDA classified this action as a Class II recall.
The reason given is the presence of particulate matter, described as a white thread-like structure found in the cartridge. The affected product was manufactured by Lupin Limited in Nagpur, India, for Lupin Pharmaceuticals, Inc., based in Naples, FL.
The recall covers two package configurations: a 2-pen pack under NDC 70748-346-02 and a 3-pen pack under NDC 70748-346-03. The recall status is listed as ongoing as of the reporting date.
Class II classification indicates a situation in which use of the product may cause temporary or medically reversible adverse effects, according to FDA recall categorization. This recall action reflects a manufacturing quality finding and does not itself state that harm has occurred.
Liraglutide remains an approved compound. Details on the scope, distribution, and resolution of this recall are being tracked through FDA recall channels.
For general background on this compound, readers can consult the compound overview.