D-0238-2026 Class III Ongoing
FDA drug recall D-0238-2026 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: 71,310 10mL vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 24, 2025
- Initiation Date
- Nov 26, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71,310 10mL vials
Product Description
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 for Recall
Subpotent product:out of specification assay results observed during long term stability testing.
Distribution Pattern
Nationwide in the USA
Code Information
Lot#: A250043, 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-0238-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026