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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