Drug FDA Class III Ongoing Sub/super-potent
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.
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, 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.
CISATRACURIUM BESYLATE · 71,310 10mL vials
NDC: 70069-161, 70069-161-01, 70069-161-10
Code info: Lot#: A250043, EXP Date 06/30/2026
Affected areas
Nationwide
Timeline
- InitiatedNov 26, 2025
- PublishedDec 24, 2025
- Recall number
- D-0238-2026
- 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.