FDA-Drug2025-12-24Class IIICHEMICAL
Somerset Therapeutics cisatracurium besylate injection recalled for subpotent drug strength
What this means
Somerset Therapeutics is recalling specific lots of cisatracurium besylate injection because testing found the drug contains less active ingredient than labeled. The affected vials may not work as intended during medical procedures. No injuries have been reported.
- If you have cisatracurium besylate with lot A240438 (expires 1/31/26) or A250125 (expires 8/31/26), do not use it
- Contact your pharmacy or hospital to verify whether your supply is affected
- Follow your healthcare provider's instructions for alternative medications if needed
The agency's original wording
Hazard
Subpotent product:out of specification assay results observed during long term stability testing.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
52,340 5mL vials
Manufactured in
300 Franklin Square Dr, Somerset, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0236-2026Want us to check the next one for you?
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