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Moderate riskFDA DrugClass II

Teva Octreotide Acetate injectable suspension recalled for sterility concerns

Teva Pharmaceuticals is recalling specific lots of Octreotide Acetate injectable suspension (20 mg) due to quality control issues at the manufacturing facility in Greece. The FDA found deficiencies that could affect sterility—the assurance that the medication is free from harmful bacteria and other microorganisms.

From the FDA notice · Read the official notice ↗ · All Teva recalls

What to do

  1. Check your medication vial for lot numbers: 4401491, 4401600, 4401603, 4401629 (expiring 9/31/2026) or 4500594, 4500786, 4500920, 4501007, 4501462 (expiring 3/31/2027)
  2. If you have an affected lot, contact your pharmacy or prescriber immediately—do not use the medication
  3. Ask your doctor or pharmacist for a replacement from a non-recalled lot
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08.
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
19,869 Cartons
Illnesses reported
None reported
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Classification
Class II
Recall number
D-0405-2026

In the FDA's words

Description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. Lot: 4401491, 4401600, 4401603, 4401629, Exp.: 9/31/2026; 4500594, 4500786, 4500920, 4501007, 4501462, Exp.: 3/31/2027. Distribution: Nationwide in the USA Affected quantity: 19,869 Cartons
Hazard
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

3 products in this recall

The agency lists each product separately. Check every one you might have.

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