Cisatracurium 20 mg multiple-dose vials recalled after subpotent assay results
Somerset Therapeutics is recalling 71,310 vials of Cisatracurium Besylate Injection, 20 mg/10 mL, after out of specification assay results during long term stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites a subpotent assay result with no stated clinical consequence.
Plain-English summary
Cisatracurium Besylate Injection USP, 20 mg/10 mL (2 mg/mL), supplied as 10 x 10 mL multiple-dose vials per carton, manufactured for Somerset Therapeutics, LLC of Hollywood, Florida, made in India, under NDC 70069-161-01, is being recalled.
The reason given in the enforcement record is a subpotent product: out of specification assay results observed during long term stability testing.
The recall covers 71,310 10mL vials from lot A250043, expiry 06/30/2026. Distribution was nationwide in the USA. The FDA has classified the action as Class III, its least serious category.
The record describes a specification failure rather than a reported patient harm. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
- Brand
- CISATRACURIUM BESYLATE
- Manufacturer
- SOMERSET THERAPEUTICS LLC
- Category
- Drug — Neuromuscular blocker
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: A250043
- EXP Date 06/30/2026
UPCs (2)
- 0370069161012
- 0370069161104
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by SOMERSET THERAPEUTICS LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · CISATRACURIUM BESYLATE
- ModerateCisatracurium 200 mg vials recalled after subpotent stability assay results
FDA (Drugs) · 2025-12-24
- ModerateCisatracurium 10 mg vials recalled after subpotent stability assay results
FDA (Drugs) · 2025-12-24
- SevereCisatracurium Besylate Injection Recalled Due to Labeling Error
FDA (Drugs) · 2021-03-03
Same manufacturer · SOMERSET THERAPEUTICS LLC
See all →- HighDexamethasone injection failed impurity specifications at product expiry testing
FDA (Drugs) · 2026-03-25
- ModerateFDA Class III Atropine Sulfate Ophthalmic Solution Recall for Specification Failures
FDA (Drugs) · 2025-01-08
- HighHaloperidol Decanoate Injections Recalled for Trace Water Contamination
FDA (Drugs) · 2024-05-29
- LowSomerset Therapeutics Recalls Brimonidine Tartrate Ophthalmic Solution
FDA (Drugs) · 2020-07-15
- LowSomerset Therapeutics Recalls Brimonidine Tartrate Ophthalmic Solution Due to Label Leaching
FDA (Drugs) · 2020-07-15
Same hazard · subpotent
See all →- ModerateCAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
- HighCompounded vasopressin syringes recalled as subpotent by IntegraDose Compounding Services
FDA (Drugs) · 2026-06-24
- ModerateSkin Rehab calming hydrocortisone balm recalled as a subpotent drug
FDA (Drugs) · 2026-04-22
- Moderateglo Skin Beauty Remedy Gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22
- ModerateRhonda Allison calming skin gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22
Similar recalls
- SevereCisatracurium Besylate Injection Recalled Due to Labeling Error
FDA (Drugs) · 2021-03-03
- ModerateFresenius Kabi Recalls Cisatracurium Vials Due to Labeling Error
FDA (Drugs) · 2016-04-20
- HighDexamethasone injection failed impurity specifications at product expiry testing
FDA (Drugs) · 2026-03-25
- SevereSagent Pharmaceuticals Recalls Atracurium Besylate Injection Due to Sterility Concerns
FDA (Drugs) · 2015-03-11
- ModerateInvaGen Recalls Amlodipine Besylate Tablets Due to Subpotency
FDA (Drugs) · 2018-10-17
- ModerateLisdexamfetamine 20 mg capsules recalled after failing dissolution at twelve month stability
FDA (Drugs) · 2025-11-05