SOMERSET THERAPEUTICS LLC recalls Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufacture
Recalled December 24, 2025 · FDA recall D-0236-2026 · SOMERSET THERAPEUTICS
Hazard
Subpotent product:out of specification assay results observed during long term stability testing. · FDA Class III
Units
52,340 5mL 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, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.
Manufacturer(s)
SOMERSET THERAPEUTICS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →