Teva Pharmaceuticals USA, Inc initiated a recall of Octreotide Acetate for Injectable Suspension on April 24, 2026. The recall is classified as Class II by the FDA. The affected product is the 30 mg single-dose kit for gluteal intramuscular use, manufactured in Greece by Pharmathen International S.A for Teva Pharmaceuticals.
The reason given is lack of assurance of sterility. This was linked to quality system deficiencies identified during a routine FDA inspection at the contract manufacturer. The recall status is listed as ongoing.
NDC numbers associated with the recall include the kit carton, vial label, tray label, and diluent label as specified in the FDA notice. The recall record is identified as D-0519-2026.
This recall reflects a manufacturing and quality system finding as reported by the FDA. It does not by itself indicate that the product has caused harm. Octreotide remains an approved compound, and this action pertains specifically to the identified lot or lots covered under this recall notice.
Readers seeking additional context on octreotide can consult the compound overview for further background.