Class IIIOngoing

Cisatracurium Besylate Injection USP recall

FDA recall D-0238-2026 · 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, 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.
Recalling company: Somerset Therapeutics, LLC
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Nov 26, 2025
FDA report date: Dec 24, 2025

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.

Source: openFDA Drug Enforcement record D-0238-2026 ↗

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