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Class III · Lower riskActive recall

Cisatracurium Besylate

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot#: A250043, EXP Date 06/30/2026
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Subpotent product:out of specification assay results observed during long term stability testing.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameCISATRACURIUM BESYLATE
Generic nameCISATRACURIUM BESYLATE
Active ingredient(s)CISATRACURIUM BESYLATE
Distributed by / forSomerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial
NDC70069-161-01
Show the full FDA record
Full product labelCisatracurium 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 firmSOMERSET THERAPEUTICS LLC
DistributionNationwide in the USA
Quantity71,310 10mL vials
Recall initiated2025-11-26
Report date2025-12-24
Recall completed—
Recall numberD-0238-2026
ClassificationClass III
FDA statusOngoing
Origin on fileSomerset NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.