Cisatracurium Besylate Injection USP recall — Class III (D-0237-2026) · pharmaranks
Class IIIOngoing
Cisatracurium Besylate Injection USP recall
FDA recall D-0237-2026 · initiated Nov 26, 2025
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Subpotent product:out of specification assay results observed during long term stability testing.
Details
Product
Cisatracurium 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.
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.