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Ongoing FDAEvent 98609 (6 months ago)

Teva Octreotide Acetate for Injectable Suspension

Octreotide Acetate for Injectable Suspension lacks assurance of sterility due to quality system deficiencies.

Moderate risk

Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Teva Pharmaceuticals USA, Inc. is recalling Octreotide Acetate for Injectable Suspension because of a lack of assurance of sterility, due to quality system deficiencies identified during a routine U.S. Food and Drug Administration (FDA) inspection at the contract manufacturer.

The products are single-dose 8 mL vials for gluteal intramuscular use in strengths of 10 mg, 20 mg, and 30 mg, manufactured in Greece by Pharmathen International S.A. and distributed nationwide in the USA. The company began the recall on March 17, 2026.

Summary by Recall Canary from the FDA notice.

More sterility failure recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:

  1. Check the FDA or company notice for instructions specific to this product.
  2. Ask your pharmacist or doctor whether your lot is affected and what to do.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

  1. Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use

    1. Strength
      20 mg
      NDC
      • 0480-9259-08
    2. Strength
      30 mg
      NDC
      • 0480-9262-08
    3. Strength
      10 mg
      NDC
      • 0480-9257-08
    4. Strength
      10 mg
      NDC
      • 0480-9257-08
      Lot
      • 4401619
      • 4501005
    5. Strength
      20 mg
      NDC
      • 0480-9259-08
      Lot
      • 4401491
      • 4401600
      • 4401603
      • 4401629
      • 4500594
      • 4500786
      • 4500920
      • 4501007
      • 4501462
    6. Strength
      30 mg
      NDC
      • 0480-9262-08
      Lot
      • 4400401
      • 4401393
      • 4401494
      • 4401604
      • 4500564
      • 4500601
      • 4500707
      • 4500796
      • 4500859
      • 4500918
      • 4500919
      • 4501006

    Some entries omit identifying details. Check the notice to confirm which units are affected.

Details

Company began the recall
Sold in

Nationwide in the USA

Event ID
98609
Recall numbers
D-0404-2026 to D-0406-2026
Company
Teva Pharmaceuticals USA, IncParsippany, New Jersey
Hazard
Sterility failure

  1. Company began the recall

  2. Added to FDA's Enforcement Report

  3. Classified by FDA

  4. In FDA's weekly enforcement report

  5. Listed on Recall Canary

  6. Summary updated

All recalls from Teva Pharmaceuticals USA, Inc

Other sterility failure recalls

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Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration