Cisatracurium Besylate Injection USP recall (SOMERSET THERAPEUTICS LLC)
DrugClass IIIOngoing
Summary: SOMERSET THERAPEUTICS LLC is recalling 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.. Reason: Subpotent product:out of specification assay results observed during long term stability testing.
What is being recalled
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.
Why
Subpotent product:out of specification assay results observed during long term stability testing.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot#: A250043, EXP Date 06/30/2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0238-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | November 26, 2025 |
| Reported | December 24, 2025 |
| Company | SOMERSET THERAPEUTICS LLC |
| Company location | Somerset, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 71,310 10mL vials |
More recalls from SOMERSET THERAPEUTICS LLC · all drug recalls · recalls from November 2025