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, Manufactur…

Recall date

November 26, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0236-2026

FDA classification

Class III

Brand / firm

SOMERSET THERAPEUTICS LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

Subpotent product:out of specification assay results observed during long term stability testing.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.