FDAHealthNovember 26, 2025
SOMERSET THERAPEUTICS LLC — 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 330
⚠️ Subpotent product:out of specification assay results observed during long term stability testing.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 26, 2025
Nationwide in the USA
What's affected?
- Product
- 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.
- UPC
- 0370069141014
- Lot code
- A240438
Additional details
Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 52,340 5mL vials.
Get Health recall alerts
Delivered to your inbox. Free. No account required.