SOMERSET THERAPEUTICS LLC recalls Cisatracurium Besylate Injection USP
- Recalling company
- SOMERSET THERAPEUTICS LLC
- Product
- 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.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Nov 26, 2025
- Reported
- Dec 24, 2025
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 71,310 10mL vials
- Lot / codes
- Lot#: A250043, EXP Date 06/30/2026
- Company location
- Somerset, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0238-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0238-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.