Cisatracurium Besylate Injection USP — Class III drug recall D-0236-2026
Ongoing recall by SOMERSET THERAPEUTICS LLC, reported 2025-12-24, distributed nationwide. Subpotent product:out of specification assay results observed during long term stability testing.
| Recall number | D-0236-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SOMERSET THERAPEUTICS LLC, Somerset, NJ, United States |
| Recall initiated | 2025-11-26 |
| Classified | 2025-12-15 |
| Reported by FDA | 2025-12-24 |
| Distributed | Nationwide (US) |
| Quantity | 52,340 |
| Reason classes | potency, specification failure |
| NDC | 70069-0141, 70069-0141-01, 70069-0141-10, 70069-0151, 70069-0151-01, 70069-0151-10 |
| Lot numbers | A240438, A250125 |
| Expiration dates | 2026-01-31, 2026-08-31 |
Product
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.
Reason for recall
Subpotent product:out of specification assay results observed during long term stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0236-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.