FDAClass II · Drug · Recalled May 13, 2026

Octreotide Acetate for Injectable Suspension recall — Teva Pharmaceuticals USA, Inc

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: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0519-2026
Brand: Teva Pharmaceuticals USA
Classification: Class II
Units affected: 2,200 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.

Affected products

Octreotide Acetate for Injectable Suspension

Companies & origin

Recalling firm location: Parsippany, NJ, United States
Firm address: 400 Interpace Pkwy Bldg A, 07054-1120

Identifying details (verbatim from the notice)

Product codes / lots: Lot: 45011002, Exp. 03/31/2027
Distribution: Nationwide in the USA
Firm notified the public via: Letter
FDA event ID: 98810
Recall initiated: April 24, 2026
FDA classified: May 5, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

Report a data error on this page