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Recall Enforment Report D-0236-2026

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by SOMERSET THERAPEUTICS LLC, originally initiated on 11-26-2025 for the 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. The product was recalled due to subpotent product:out of specification assay results observed during long term stability testing.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0236-202611-26-202512-24-2025Class III52,340 5mL vialsCisatracurium 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.Subpotent product:out of specification assay results observed during long term stability testing.Ongoing
D-0237-202611-26-202512-24-2025Class III28,660 20mL vialsCisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.Subpotent product:out of specification assay results observed during long term stability testing.Ongoing
D-0238-202611-26-202512-24-2025Class III71,310 10mL vialsCisatracurium 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.Subpotent product:out of specification assay results observed during long term stability testing.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
70069-141Cisatracurium Besylate Cisatracurium BesylateInjectionIntravenousSomerset Therapeutics, LlcHuman Prescription Drug
70069-151Cisatracurium Besylate Cisatracurium BesylateInjectionIntravenousSomerset Therapeutics, LlcHuman Prescription Drug
70069-161Cisatracurium Besylate Cisatracurium BesylateInjectionIntravenousSomerset Therapeutics, LlcHuman Prescription Drug