Class II

Drug Recall: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manu

Teva Pharmaceuticals USA, Inc · March 17, 2026

Reason for Recall

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

Product Description

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

19,869 Cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0405-2026

Status: ongoing

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