SOMERSET THERAPEUTICS LLC recalls Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufa
Recalled December 24, 2025 · FDA recall D-0238-2026 · SOMERSET THERAPEUTICS
Hazard
Subpotent product:out of specification assay results observed during long term stability testing. · FDA Class III
Units
71,310 10mL vials
Sold at
Nationwide in the USA
Description
Subpotent product:out of specification assay results observed during long term stability testing.
Product
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.
Manufacturer(s)
SOMERSET THERAPEUTICS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →