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Back to Drug Recalls Center
Home Drug Recalls D-0519-2026
Class II — Moderate Risk Severity Status: Ongoing Authority: FDA

OCTREOTIDE ACETATE

Recalling Firm / Manufacturer: Teva Pharmaceuticals USA, Inc (Parsippany, NJ, United States)
FDA Recall Number: D-0519-2026
View FDA Source
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
OCTREOTIDE ACETATE
Generic Name
OCTREOTIDE ACETATE
Active Substance(s)
Not provided by source
Administration Route
Intramuscular
National Drug Code (NDC)
0480-9257
Total Quantity Recalled
2,200 kits
Official Reason for Recall
Specific hazard or quality defect cited by the FDA

According to the official FDA enforcement report:

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

Full Product Description
Packaging specifications and labeling details

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.

Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
May 13, 2026
Firm Initiation Date
April 24, 2026
FDA Classification Date
May 05, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot: 45011002, Exp. 03/31/2027
Distribution Information
Geographic scope of affected shipments

Nationwide in the USA

Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.

Official Source Provenance

Verified regulatory citation from U.S. FDA OpenFDA

Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0519-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508603UTCC
View Official FDA Source

System Notice

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