FDA Recall D-0405-2026

Teva Pharmaceuticals USA, Inc · Parsippany, NJ

Class II Ongoing 58 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

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

Quantity: 19,869 Cartons

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.

Recall record

Recall number: D-0405-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2026-03-17
Classified by FDA Center: 2026-03-27
FDA published: 2026-04-01
Recalling firm: Teva Pharmaceuticals USA, Inc
Firm location: Parsippany, NJ

Drug identification

Brand name(s): OCTREOTIDE ACETATE
Generic name(s): OCTREOTIDE ACETATE
Manufacturer(s): Teva Pharmaceuticals, Inc.
NDC(s): 0480-9257, 0480-9259, 0480-9262
Route(s): INTRAMUSCULAR

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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