Class III
Ongoing
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.
This recall is currently active, issued December 24, 2025. It was issued by Somerset Therapeutics Llc.
- Company
- Somerset Therapeutics Llc
- Recall Initiated
- November 26, 2025
- Posted
- December 24, 2025
- Recall Number
- D-0237-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 28,660 20mL vials
- Firm Location
- Somerset, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Subpotent product:out of specification assay results observed during long term stability testing.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: A250020, Exp Date 06/30/2026
More recalls by Somerset Therapeutics Llc
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Ther...
Jan 8, 2025 · Class III
Other recent Class III Drug recalls
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Via...
Slate Run Pharmaceuticals
· Mar 4, 2026
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceutica...
Unichem Pharmaceuticals Usa Inc.
· Feb 18, 2026
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL),...
Haleon Us Holdings Llc
· Feb 4, 2026
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceutic...
Novadoz Pharmaceuticals Llc
· Feb 4, 2026
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd.,...
Cipla Usa, Inc.
· Jan 28, 2026