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Drug FDA Class II Ongoing Contamination / non-sterility

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.

Teva Pharmaceuticals USA, Inc Published Apr 1, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Teva Pharmaceuticals USA, Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Hazards

Lack of Sterility Assurance · primary

Affected products (1)

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.

OCTREOTIDE ACETATE · 1,897 Cartons

NDC: 0480-9257, 0480-9259, 0480-9262, 0480-9257-08, 0480-9256-01, 0480-9263-21, 0480-9259-08, 0480-9258-01, 0480-9262-08, 0480-9260-01
Lot codes: 4401619
Code info: Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027.

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 17, 2026
  2. Published
    Apr 1, 2026
Recall number
D-0404-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.