Semaglutide-Glycine-Cyanocobalamin Injectables Recalled for Lack of Sterility Assurance

Key Takeaways

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for semaglutide-glycine-cyanocobalamin injectables, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials.
• The recall was initiated by Payless Compounders LLC due to sterility assurance concerns, a quality issue that may cause temporary or medically reversible adverse health consequences.
• Semaglutide injections are used to treat patients with type 2 diabetes to help with weight loss and to lower the risk of heart attack, stroke, and kidney disease.

The FDA has issued a Class II recall for semaglutide-glycine-cyanocobalamin injectables, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials. This medication is manufactured by Northwest Compounders in Beaverton, Oregon and is being recalled by Payless Compounders LLC in Beaverton, Oregon. The recall was initiated on March 6, 2026, but was classified as a Class II recall on April 13, 2026. This recall affects 91 vials.

The recall was prompted by a lack of assurance of sterility, specifically for Lot Number 01-27-2026@14S.5. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, and the probability of serious adverse health consequences is low. Payless notified the public via letter; no public press release has been issued for this recall.

Semaglutide injections are a prescription medication used to treat type 2 diabetes. Injections are used together with diet to control weight and lower the risk of heart disease, stroke, and kidney disease. Pharmacists should identify and quarantine Lot 01-27-2026@14S.5, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. April 22, 2026. Accessed April 23, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219327