CISATRACURIUM BESYLATE
Recalling Firm / Manufacturer: SOMERSET THERAPEUTICS LLC
(Somerset, NJ, United States)
FDA Recall Number: D-0238-2026
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
CISATRACURIUM BESYLATE
Generic Name
CISATRACURIUM BESYLATE
Active Substance(s)
Cisatracurium Besylate
Administration Route
Intravenous
National Drug Code (NDC)
70069-161
Total Quantity Recalled
71,310 10mL vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Subpotent product:out of specification assay results observed during long term stability testing.
Full Product Description
Packaging specifications and labeling details
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
December 24, 2025
Firm Initiation Date
November 26, 2025
FDA Classification Date
Dec 15, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot#: A250043, EXP Date 06/30/2026
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
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-0238-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508608UTCC