Liraglutide Injections Recalled Due to the Presence of Particulate Matter
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for liraglutide injections, 18mg/3mL (6mg/mL), affecting 217 621 pen injectors.
- The recall was initiated by Lupin Pharmaceuticals, Inc due to the presence of particulate matter, a quality issue that may cause temporary or medically reversible adverse health consequences.
- Liraglutide injections are used to treat people with type 2 diabetes by lowering blood sugar and reducing the risk of heart attack or stroke. They can also help people who are obese or overweight lose weight when used with diet and exercise.
The FDA has issued a Class II recall for liraglutide injections, 18mg/3mL (6mg/mL), affecting 217 621 pen injectors. This medication is manufactured by Lupin Limited in Nagpur, India and is being recalled by Lupin Pharmaceuticals, Inc based in Naples, Florida. The recall was initiated on April 24, 2026, and received a Class II classification on May 19, 2026.
The recall was initiated due to the presence of particulate matter; a white thread-like structure was discovered in the cartridge. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is low. Lupin Pharmaceuticals sent out a public notice via letter; no public press release has been issued for this recall.
Liraglutide is a prescription weight-loss medication used in combination with diet and exercise for people with obesity. It is also used to lower blood sugar in people with type 2 diabetes. Liraglutide injections can also reduce the risk of heart attack or stroke in people with type 2 diabetes or heart disease. Pharmacists should identify and quarantine the affected batches, remove them from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. May 27, 2026. Accessed May 27, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219870
