Quick Facts at a Glance
- Recall Date
- April 24, 2026
- Hazard Level
- HIGH
- Brands
- OCTREOTIDE ACETATE, Teva Pharmaceuticals, Inc.
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- OCTREOTIDE ACETATE, Teva Pharmaceuticals, Inc.
- Model numbers
- Lot: 45011002, Exp. 03/31/2027
- UPC codes
- 0480-9257, 0480-9259, 0480-9262, 0480-9257-08, 0480-9256-01, 0480-9263-21, 0480-9259-08, 0480-9258-01 +2 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 24, 2026
Reported by FDA DRUG
May 13, 2026
RecallRadar source check
May 20, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter
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Full Description
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.. Generic: OCTREOTIDE ACETATE; Brand: OCTREOTIDE ACETATE. 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. Quantity: 2,200 kits. Distribution: Nationwide in the USA
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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