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:4400401, Exp.: 6/30/2026, 4401393, 4401494, 4401604, Exp.: 9/31/2026, 4500564, 4500601 +7 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 for Injectable Suspension is a prescription medication used to treat conditions such as neuroendocrine tumors and acromegaly. It is administered by intramuscular injection in the gluteal region under medical supervision.
Why This Is Dangerous
The absence of sterility assurance raises risk of infection or contamination in patients receiving injections, potentially leading to serious adverse events.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Medical treatment interruption or infection risk for patients dependent on octreotide therapy, with potential burden on healthcare systems due to recall communication and product replacement.
Practical Guidance
How to identify if yours is affected
- Verify NDC 0480-9262-08 on the label
- Cross-check the lot numbers listed in the recall with your packaging
- Check expiration dates listed: 6/30/2026; 9/31/2026; 3/31/2027
- Confirm distributor and pharmacy of record as Teva Pharmaceuticals USA, Inc.
Where to find product info
Recall notices and lot-specific information are available on FDA enforcement pages and Teva communications.
What timeline to expect
Recall communications by letter; replacement or guidance may take several weeks (typical 4-6 weeks for related recalls).
If the manufacturer is unresponsive
- File a complaint with Teva via official recall channels
- If unresolved, contact the FDA consumer hotline or your state health department for guidance
How to prevent similar issues
- Whenever possible, source Rx drugs from licensed pharmacies
- Be alert for recalls on prescription medications and verify NDCs when receiving shipments
- Ask healthcare providers about sterile manufacturing and withdrawal plans for medications
Documentation advice
Keep copy of recall letter, record lot numbers and expiration dates, save packaging, document all communications with Teva and healthcare providers.
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Product Details
Model numbers/lot information: Lot 4400401; Exp. 6/30/2026. Lot 4401393; Lot 4401494; Lot 4401604; Exp. 9/31/2026. Lot 4500564; Lot 4500601; Lot 4500707; Lot 4500796; Lot 4500859; Lot 4500918; Lot 4500919; Lot 4501006; Exp. 3/31/2027. NDC: 0480-9262-08. Sold nationwide in the USA. Manufacturer: Pharmathen International S.A. (Greece). Manufactured for Teva Pharmaceuticals, Parsippany, NJ. Quantity: 21,930 cartons. Product: Octreotide Acetate for Injectable Suspension, 30 mg, 8 mL single-dose vial. Rx only.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Octreotide Acetate for Injectable Suspension, 30 mg
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Safety Guide
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