FDA-Drug2025-12-24Class IIICHEMICAL
Somerset Therapeutics cisatracurium besylate injection recalled for subpotent drug strength
What this means
Somerset Therapeutics is recalling cisatracurium besylate injection (200mg/20mL vials, Lot #A250020, expiration 06/30/2026) because stability testing found the drug's strength fell below required standards. This means the medication may not work as intended during medical procedures.
- If you have Lot #A250020 (expiration 06/30/2026), stop using it immediately
- Contact your pharmacy or healthcare facility to confirm whether you have affected vials
- Speak with your doctor or pharmacist about obtaining a replacement supply
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
28,660 20mL vials
Manufactured in
300 Franklin Square Dr, Somerset, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0237-2026Want us to check the next one for you?
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