FDAFDA · Food and drugs·Recall number D-0236-2026
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.
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
- 0370069141014
- Lot
- Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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