D-0237-2026 Class III Ongoing
FDA drug recall D-0237-2026 was initiated by SOMERSET THERAPEUTICS LLC on Nov 26, 2025 and is designated Class III. Reason for recall: Subpotent product:out of specification assay results observed during long term stability testing. The recall status is ongoing. Affected quantity: 28,660 20mL vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 24, 2025
- Initiation Date
- Nov 26, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,660 20mL vials
Product Description
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.
Reason for Recall
Subpotent product:out of specification assay results observed during long term stability testing.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: A250020, Exp Date 06/30/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0237-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026