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Verified · FDAClass II — Possible RiskMedications

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use Recall 2026

OCTREOTIDE ACETATEIssued April 24, 2026Updated Reviewed by the Recall Watch editorial team

OCTREOTIDE ACETATE Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vi — recalled per FDA on 4/24/2026. Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer..

Agency
FDA
Issued
Apr 24, 2026
Brand
OCTREOTIDE ACETATE
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued April 24, 2026 · Last synced Nov 1, 2026

What's recalled

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.

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Why it was recalled

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

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot: 45011002
Exp. 03/31/2027
Where was it sold
1 state

Nationwide in the USA

nationwide
Official noticefda.gov
More recalls like this
7 related — by brand, contaminant, and category

Frequently asked questions

Is the OCTREOTIDE ACETATE recall still active?

Yes, this recall is currently active as of April 24, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot: 45011002, Exp. 03/31/2027. Check the label on your product.

What should I do if I have the recalled OCTREOTIDE ACETATE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.