Unlikely to cause harm — often a labeling or packaging issue.
Subpotent product:out of specification assay results observed during long term stability testing.
| Brand name | CISATRACURIUM BESYLATE |
| Generic name | CISATRACURIUM BESYLATE |
| Active ingredient(s) | CISATRACURIUM BESYLATE |
| Distributed by / for | Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial |
| NDC | 70069-151-01 |
| Full product label | 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. |
| Recalling firm | SOMERSET THERAPEUTICS LLC |
| Distribution | Nationwide in the USA |
| Quantity | 28,660 20mL vials |
| Recall initiated | 2025-11-26 |
| Report date | 2025-12-24 |
| Recall completed | — |
| Recall number | D-0237-2026 |
| Classification | Class III |
| FDA status | Ongoing |
| Origin on file | Somerset NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗