Drug Recall: 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-do
SOMERSET THERAPEUTICS LLC · November 26, 2025
Reason for Recall
Subpotent product:out of specification assay results observed during long term stability testing.
Product Description
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.
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
52,340 5mL vials
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0236-2026
Status: ongoing
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