OCTREOTIDE ACETATE
Recalling Firm / Manufacturer: Teva Pharmaceuticals USA, Inc
(Parsippany, NJ, United States)
FDA Recall Number: D-0405-2026
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
19,869 Cartons
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, 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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
April 01, 2026
Firm Initiation Date
March 17, 2026
FDA Classification Date
Mar 27, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot: 4401491, 4401600, 4401603, 4401629, Exp.: 9/31/2026; 4500594, 4500786, 4500920, 4501007, 4501462, Exp.: 3/31/2027.
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-0405-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508604UTCC