FDA Drug recall 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: Somerse…
- FDA Drug
- Class III
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class III recall of Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerse… by Somerset Therapeutics, citing subpotent product:out of specification assay results observed during long term stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0238-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-11-26 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Somerset Therapeutics |
| Distribution | US |
Product
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
Subpotent product:out of specification assay results observed during long term stability testing.
Identifiers
| ndc | 70069-161-01 |
|---|---|
| ndc | 70069-161-10 |
| code_info | Lot#: A250043, EXP Date 06/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0238-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.