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
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
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: 4401619, Exp.: 09/30/2026, 4501005, 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
- Sold at
- Unknown
- 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 a prescription medication used to treat certain hormone-secreting tumors and related conditions. It is administered by intramuscular injection, often in a clinical setting.
Why This Is Dangerous
The hazard is a sterility concern that could lead to contamination and infection if administered. The issue stems from quality control deficiencies identified during an FDA inspection of the contract manufacturer.
Industry Context
This recall is not presented as part of a broader industry pattern in the provided materials.
Real-World Impact
Patients currently receiving this medication may be affected. The recall covers nearly 1,900 cartons distributed nationwide, requiring clinicians to switch patients to alternative therapies as directed by Teva.
Practical Guidance
How to identify if yours is affected
- Verify the NDC 0480-9257-08 on the product label
- Check lot numbers 4401619 and 4501005
- Confirm expiry dates 09/30/2026 and 03/31/2027
- Confirm packaging states single-dose 8 mL vial, 10 mg
Where to find product info
FDA enforcement page for recall D-0404-2026 and Teva recall communications
What timeline to expect
Refund or replacement policies are not specified in the recall materials. Follow Teva guidance for next steps.
If the manufacturer is unresponsive
- Contact Teva Pharmaceuticals USA, Inc for guidance
- If no response within a reasonable timeframe, contact your healthcare provider or seek FDA MedWatch reporting
How to prevent similar issues
- Verify supplier reliability with licensed pharmacies
- Check lot numbers and expiry dates before administration
- Avoid third-party suppliers for sterile injectables when possible
- Ask clinicians to verify sterility certifications of suppliers
Documentation advice
Keep the recall notice and all packaging, labeling, and correspondence. Document lot numbers, expiry dates, and dates of contact with Teva or healthcare providers.
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Product Details
Model numbers/lot numbers: Lot 4401619; Exp. 09/30/2026; 4501005; Exp. 03/31/2027 Where sold: Nationwide in the USA When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Manufactured in Greece by Pharmathen International S.A. for Teva Pharmaceuticals
- Sterility concerns identified during an FDA inspection
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Safety Guide
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