Teva Pharmaceuticals USA, Inc. initiated a recall of Octreotide Acetate for Injectable Suspension on March 17, 2026. The FDA has classified this action as a Class II recall. The recall applies to the 10 mg, single-dose 8 mL vial in kit product, NDC 0480-9257-08, intended for gluteal intramuscular use.
The stated reason for the recall is lack of assurance of sterility. This finding stems from quality system deficiencies identified during a routine FDA inspection at the contract manufacturer, Pharmathen International S.A., located in Rodopi, Greece. The product was manufactured for Teva Pharmaceuticals, based in Parsippany, New Jersey.
According to FDA records, the recall status is currently listed as ongoing. The recall identification number associated with this action is D-0404-2026. No additional details beyond the classification, reason, firm, and initiation date have been provided in the current record.
This report reflects only the information contained in the FDA recall listing as of the stated date. Readers can consult the compound overview for further background on octreotide.