FDA-Drug2025-12-24Class IIICHEMICAL
Somerset Therapeutics cisatracurium besylate injection recalled for subpotent drug substance
LABEL MIX UPNationwide distribution
Stop using Somerset Therapeutics cisatracurium besylate
Somerset Therapeutics is recalling cisatracurium besylate injection (a muscle relaxant used during surgery) because stability testing found the drug strength fell below the required standard. Lot A250043 with expiration date 06/30/2026 is affected. The company has not reported any injuries.
- Stop using cisatracurium besylate injection from lot A250043 (NDC 70069-161-01) immediately
- Contact your pharmacy or hospital to verify you have not received affected vials
- Ask your healthcare provider or pharmacist for guidance on alternative medications if needed
- Report any adverse effects to FDA MedWatch at 1-888-SAFEMED or online
Hazard
Subpotent product:out of specification assay results observed during long term stability testing.
Sold states
Nationwide in the USA
Affected count
71,310 10mL vials
Manufactured in
300 Franklin Square Dr, Somerset, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0238-2026Don't want to check this manually?
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