The FDA MedWatch alert reports a Class II recall of Octreotide Acetate for Injectable Suspension, 20 mg single-dose 8 mL vial, for gluteal intramuscular use. The recall is due to lack of assurance of sterility, stemming from quality system deficiencies identified during a routine FDA-ordered inspection at the contract manufacturer.
Product is manufactured in Greece by Pharmathen International S.A. and supplied to Teva Pharmaceuticals (Parsippany, NJ) for distribution in the United States.
The NDC is 0480-9259-08. The recalling firm is Teva Pharmaceuticals USA, Inc.
Details available are limited to the recall classification and the underlying sterility concern detected during regulatory inspection. The notice does not provide data on lots affected, specific sterility failure modes, test results, or remediation actions beyond identifying the quality-system deficiencies and the potential sterility risk.
Clinicians should review any affected lot information in the official recall communications and follow Teva’s guidance for product disposition, reporting, and patient safety measures as released by the firm and FDA. If additional information is required, refer to the FDA MedWatch notice or Teva’s recall updates.
FDA MedWatch published a clinical safety alert in Pharmacology on 01 Apr 2026.
The item focuses on OCTREOTIDE ACETATE: Class II recall update.
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