FDAFDA · Food and drugs·Recall number D-0519-2026
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.
Published May 13, 2026 · Recall initiated: April 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- OCTREOTIDE ACETATE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot: 45011002, Exp. 03/31/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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