Teva Pharmaceuticals USA, Inc initiated a recall of Octreotide Acetate for Injectable Suspension on March 17, 2026. The U.S. Food and Drug Administration has classified this action as a Class II recall, identified as event D-0405-2026.
The reason given is a lack of assurance of sterility. This followed quality system deficiencies identified during a routine FDA inspection at the contract manufacturer, Pharmathen International S.A. in Greece.
The recalled product is Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, supplied as a single-dose 8 mL vial in a kit, NDC 0480-9259-08. It is manufactured in Greece by Pharmathen International S.A. for Teva Pharmaceuticals in Parsippany, New Jersey.
The recall status is listed as ongoing. This classification and reason reflect quality system findings reported to the FDA and do not by themselves indicate that any adverse event has occurred.
Additional details on this recall are available through the FDA's recalls and safety alerts database. Readers seeking general background on this compound can consult the octreotide overview page.