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FDAClass II

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Singl… Recalled: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U…

Octreotide Acetate for Injectable Suspension, for gluteal… was recalled on March 17, 2026 in cooperation with the U.S. Food and Drug Administration because lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection…

Is my unit affected?

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 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 0480-9262-08.

Model, lot & date codes to check

Lot:4400401, Exp.: 6/30/2026; 4401393, 4401494, 4401604, Exp.: 9/31/2026; 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, 4501006, Exp.: 3/31/2027.

Units affected: 21,930 Cartons

Where it was sold: Nationwide in the USA

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's 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.

Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: Teva Pharmaceuticals USA, Inc

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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