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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Octreotide Acetate Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: March 24, 2026
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Summary

Teva Pharmaceuticals USA, Inc. is voluntarily recalling 43,696 cartons of Octreotide Acetate for Injectable Suspension (10 mg, 20 mg, and 30 mg strengths) because of quality system deficiencies at the contract manufacturer that mean the sterility of the product cannot be guaranteed. This drug is a prescription medication used via gluteal intramuscular injection. Consumers should be aware that using a non-sterile injectable medication can lead to serious, potentially life-threatening infections.

Risk

Deficiencies in the manufacturer's quality system mean the sterility of these injectable vials is not assured. Injecting a product that is not sterile can introduce bacteria or other contaminants directly into the body, posing a risk of severe localized or systemic infections.

What You Should Do

  1. If you have health concerns regarding this medication, contact your healthcare provider or pharmacist.
  2. Check your medication carton for Octreotide Acetate for Injectable Suspension in 10 mg (NDC 0480-9257-08), 20 mg (NDC 0480-9259-08), or 30 mg (NDC 0480-9262-08) strengths. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact Teva Pharmaceuticals USA, Inc. or your distributor to arrange for the return of any remaining vials.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Octreotide Acetate for Injectable Suspension (10 mg)
Variants: 10 mg, Single-dose 8 mL vial
Lot Numbers:
4401619 (Exp.: 09/30/2026)
4501005 (Exp.: 03/31/2027)
NDC:
0480-9257-08

Manufactured in Greece by Pharmathen International S.A.

Product: Octreotide Acetate for Injectable Suspension (20 mg)
Variants: 20 mg, Single-dose 8 mL vial
Lot Numbers:
4401491 (Exp.: 9/31/2026)
4401600 (Exp.: 9/31/2026)
4401603 (Exp.: 9/31/2026)
4401629 (Exp.: 9/31/2026)
4500594 (Exp.: 3/31/2027)
4500786 (Exp.: 3/31/2027)
4500920 (Exp.: 3/31/2027)
4501007 (Exp.: 3/31/2027)
4501462 (Exp.: 3/31/2027)
NDC:
0480-9259-08

Manufactured in Greece by Pharmathen International S.A.

Product: Octreotide Acetate for Injectable Suspension (30 mg)
Variants: 30 mg, Single-dose 8 mL vial
Lot Numbers:
4400401 (Exp.: 6/30/2026)
4401393 (Exp.: 9/31/2026)
4401494 (Exp.: 9/31/2026)
4401604 (Exp.: 9/31/2026)
4500564 (Exp.: 3/31/2027)
4500601 (Exp.: 3/31/2027)
4500707 (Exp.: 3/31/2027)
4500796 (Exp.: 3/31/2027)
4500859 (Exp.: 3/31/2027)
4500918 (Exp.: 3/31/2027)
4500919 (Exp.: 3/31/2027)
4501006 (Exp.: 3/31/2027)
NDC:
0480-9262-08

Manufactured in Greece by Pharmathen International S.A.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98609
Status: Active
Manufacturer: Teva Pharmaceuticals USA, Inc
Sold By: Hospitals; Infusion Centers; Wholesalers
Manufactured In: Greece, United States
Units Affected: 3 products (1,897 Cartons; 19,869 Cartons; 21,930 Cartons)
Distributed To: Nationwide
Agency Last Updated: March 27, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.