FDAFDA · Food and drugs·Recall number D-0238-2026
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.
Published December 24, 2025 · Recall initiated: November 26, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent product:out of specification assay results observed during long term stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CISATRACURIUM BESYLATE
- Manufacturer
- SOMERSET THERAPEUTICS LLC
- Distributor
- Nationwide in the USA
- UPC
- 0370069161012
- Lot
- Lot#: A250043, EXP Date 06/30/2026
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.