Teva Pharmaceuticals USA, Inc initiated a recall of Octreotide Acetate for Injectable Suspension on March 17, 2026. The recall is classified as Class II by the FDA. The affected product is the 30 mg single-dose 8 mL vial in kit, for gluteal intramuscular use, NDC 0480-9262-08. It was manufactured in Greece by Pharmathen International S.A. for Teva Pharmaceuticals.
The stated reason for the recall is lack of assurance of sterility. This followed quality system deficiencies identified during a routine FDA inspection at the contract manufacturer. The recall status is listed as ongoing.
This action pertains specifically to the identified lot and manufacturing issue described in the recall notice. The recall classification and reason are reported here as stated by the FDA and do not by themselves indicate that harm has occurred. Readers can consult the compound overview for additional context on octreotide.