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High risk Drugs & MedicationsClass II

Teva Octreotide Acetate 10mg Injection Recall

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in G

Updated March 17, 2026

Teva Pharmaceuticals is recalling Octreotide Acetate 10 mg injectable suspension due to manufacturing quality control failures that mean the sterility of the medication cannot be guaranteed.

Is the Teva Pharmaceuticals USA, Inc recalled? Yes. This product was recalled by FDA on March 17, 2026. Details below.

What is recalled

Octreotide Acetate for Injectable Suspension, 10 mg, single-dose 8 mL vial in kit, for gluteal intramuscular use. NDC 0480-9257-08. Manufactured in Greece by Pharmathen International S.A., Rodopi, 693 00 Greece for Teva Pharmaceuticals, Parsippany, NJ 07054. Prescription only.

Am I affected

You're affected if you have a prescription for Octreotide Acetate 10 mg injectable suspension with NDC 0480-9257-08 dispensed from a pharmacy.

What to do right now

Do not use this medication. Contact your prescribing doctor or pharmacist immediately about the recall. They will advise you on next steps and provide a safe replacement if needed.

The 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.

Brands affected

Teva Pharmaceuticals USA, Inc
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0404-2026
Classification
Class II
Recalled
March 17, 2026
Read the official notice

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