Octreotide Acetate 30mg Class II Recall - Sterility Concerns

FDA initiated Class II recall D-0406-2026 for Octreotide Acetate for Injectable Suspension 30mg (Rx only, single-dose 8mL vials) manufactured by Pharmathen International S.A. in Greece and distributed by Teva Pharmaceuticals USA, Inc. The recall was triggered by quality system deficiencies identified during a routine FDA inspection at the contract manufacturer, raising concerns about sterility assurance of the product. Distribution was nationwide across the United States.

Healthcare providers, pharmacies, and patients should verify their inventory for any remaining stock of the affected product and quarantine recalled units immediately. Pharmacies should notify patients who may have received this medication. No specific return deadline is stated, but the recall is ongoing. Class II recalls typically address products that may cause temporary or reversible health consequences if used. Compliance teams should monitor FDA communications for updates on lot numbers and further instructions.