Quick Facts at a Glance
- Recall Date
- March 17, 2026
- Hazard Level
- HIGH
- Brands
- OCTREOTIDE ACETATE, Teva Pharmaceuticals, Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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.
- Product type
- Octreotide Acetate Injectable Suspension
- Model numbers
- Lot: 4401491, 4401600, 4401603, 4401629, Exp.: 9/31/2026, 4500594, 4500786, 4500920 +3 more
- 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
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 17, 2026
Reported by FDA DRUG
April 1, 2026
RecallRadar source check
April 13, 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
About This Product
Octreotide acetate injectable suspension is used to treat conditions like acromegaly and certain tumors. It is administered by a healthcare professional via intramuscular injection.
Why This Is Dangerous
A sterility defect can lead to contamination and serious infection in patients receiving injections.
Industry Context
This recall is tied to an isolated contract manufacturer issue and does not indicate a widespread industry pattern in the provided data.
Real-World Impact
Patients and healthcare providers must stop use and seek guidance. The recall is active and affects nearly 20,000 cartons nationwide.
Practical Guidance
How to identify if yours is affected
- Verify NDC 0480-9259-08 on the product label.
- Note expiration dates: 9/31/2026 and 3/31/2027.
Where to find product info
Recall notices and lot information are posted by FDA and Teva; refer to Teva’s site and the FDA enforcement page for details.
What timeline to expect
Recall is active as of 2026-03-17. Guidance on replacements or refunds will be provided by Teva via recall communications (letters).
If the manufacturer is unresponsive
- Document all communications with Teva and healthcare providers.
- If Teva is slow to respond, contact your pharmacist or seek guidance from your healthcare provider.
How to prevent similar issues
- Only obtain prescription meds from licensed pharmacies.
- Do not accept suspect shipments or unlabeled vials.
- Verify lot numbers and expiration dates before administration.
Documentation advice
Keep recall notices, product packaging, and any correspondence with Teva or healthcare providers. Record any adverse events and report them to the FDA if they occur.
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Product Details
Product: Octreotide Acetate for Injectable Suspension Strength/Volume: 20 mg, 8 mL single-dose vial Form: Injectable suspension Rx: Yes (Rx only) NDC: 0480-9259-08 Manufactured in: Pharmathen International S.A., Rodopi, 693 00 Greece Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054 Quantity: 19,869 cartons Distribution: Nationwide in the USA Lot/Exp: Lot 4401491, 4401600, 4401603, 4401629; Exp. 9/31/2026 Lot: 4500594, 4500786, 4500920, 4501007, 4501462; Exp. 3/31/2027
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Expiration dates: 9/31/2026 and 3/31/2027
- Manufactured for Teva Pharmaceuticals USA, Inc.
- Manufactured in Greece by Pharmathen International S.A.
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Safety Guide
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