Drug FDA Class III Ongoing Sub/super-potent
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.
SOMERSET THERAPEUTICS LLC Published Dec 24, 2025
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 40/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact SOMERSET THERAPEUTICS LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Subpotent product:out of specification assay results observed during long term stability testing.
Hazards
Subpotency · primary
Affected products (1)
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.
CISATRACURIUM BESYLATE · 52,340 5mL vials
NDC: 70069-141, 70069-151, 70069-141-01, 70069-141-10, 70069-151-01, 70069-151-10
Code info: Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
Affected areas
Nationwide
Timeline
- InitiatedNov 26, 2025
- PublishedDec 24, 2025
- Recall number
- D-0236-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.