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Verified · FDAClass II — Possible RiskMedications

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

OCTREOTIDE ACETATEIssued March 17, 2026Updated Reviewed by the Recall Watch editorial team

OCTREOTIDE ACETATE Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greec — recalled per FDA on 3/17/2026. 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
Mar 17, 2026
Brand
OCTREOTIDE ACETATE
Distribution
1 states
Lots affected
11
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 March 17, 2026 · Last synced Nov 1, 2026

What's recalled

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, 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.

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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
11 lots called out

Affected Lot Numbers

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

Lot Number
Lot: 4401491
4401600
4401603
4401629
Exp.: 9/31/2026
4500594
4500786
4500920
4501007
4501462
Exp.: 3/31/2027.
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 March 17, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot: 4401491, 4401600, 4401603, 4401629, Exp.: 9/31/2026, 4500594, 4500786, 4500920, 4501007, 4501462, Exp.: 3/31/2027.. 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.