Teva Pharmaceuticals USA, Inc recalls Octreotide Acetate for Injectable Suspension
- Recalling company
- Teva Pharmaceuticals USA, Inc
- Product
- 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.
- Reason
- Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 24, 2026
- Reported
- May 13, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 2,200 kits
- Lot / codes
- Lot: 45011002, Exp. 03/31/2027
- Company location
- Parsippany, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0519-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0519-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.