SOMERSET THERAPEUTICS LLC: Drug Recall
Recall #D-0238-2026 · 11/26/2025
Class III: Low Risk
Recall Details
- Recall Number
- D-0238-2026
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- SOMERSET THERAPEUTICS LLC
- Status
- Ongoing
- Date Initiated
- 11/26/2025
- Location
- Somerset, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71,310 10mL vials
Reason for Recall
Subpotent product:out of specification assay results observed during long term stability testing.
Product Description
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.
Distribution Pattern
Nationwide in the USA
Other Recalls by SOMERSET THERAPEUTICS LLC
- Class III: Low Risk 11/26/2025
- Class III: Low Risk 11/26/2025
- Class III: Low Risk 12/16/2024
- Class II: Risk 04/24/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.