Drug Recall: 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
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, 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.
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
71,310 10mL vials
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0238-2026
Status: ongoing
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