Cisatracurium Besylate Injection USP recall
FDA recall D-0236-2026 · initiated Nov 26, 2025
SOMERSET THERAPEUTICS LLC recalled Cisatracurium Besylate Injection USP in Nov 2025 — an FDA Class III recall (D-0236-2026) because Subpotent product:out of specification assay results observed during long term stability testing.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Subpotent product:out of specification assay results observed during long term stability testing.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 52,340 5mL vials
Details
- 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.
- Recalling company
- Somerset Therapeutics, LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Nov 26, 2025
- FDA report date
- Dec 24, 2025
Frequently asked
- Was Cisatracurium Besylate Injection USP recalled?
- SOMERSET THERAPEUTICS LLC recalled Cisatracurium Besylate Injection USP in Nov 2025 — an FDA Class III recall (D-0236-2026) because Subpotent product:out of specification assay results observed during long term stability testing. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Cisatracurium Besylate Injection USP recalled?
- Per the FDA enforcement record, the reason for recall D-0236-2026 was: Subpotent product:out of specification assay results observed during long term stability testing.
- Is a recalled Cisatracurium Besylate Injection USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cisatracurium Besylate Injection USP are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0236-2026.