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High risk Drugs & MedicationsClass II

Teva Octreotide Acetate 20mg Recall

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in G

Updated March 17, 2026

Teva Pharmaceuticals is recalling Octreotide Acetate 20 mg injectable suspension due to sterility concerns from manufacturing defects. The medication may not be sterile, posing a risk of serious infection if injected.

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, 20 mg, single-dose 8 mL vial in kit (prescription only), NDC 0480-9259-08, manufactured by Pharmathen International S.A. in Greece for Teva Pharmaceuticals.

Am I affected

You're affected if you have a prescription bottle or kit of Octreotide Acetate 20 mg (8 mL vial) with NDC number 0480-9259-08 on the label.

What to do right now

Do not use this medication. Contact your pharmacy or doctor immediately to obtain a replacement from a non-affected lot or an alternative medication. Do not discard the vial until you have spoken with your pharmacist or physician.

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-0405-2026
Classification
Class II
Recalled
March 17, 2026
Read the official notice

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