CLASS III ONGOING Drug recall · Reported 24 Dec 2025 · FDA Enforcement Report
Cisatracurium Besylate Injection USP, 200mg/*(10mg/mL) recalled
Somerset Therapeutics is recalling Cisatracurium Besylate Injection USP, 200mg/*(10mg/mL), mL Single-dose Vials per, distributed nationwide in the US. The recall was initiated on 26 Nov 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0237-2026
- FDA event ID
- 98063
- Recalling firm
- Somerset Therapeutics, Somerset, NJ
- Manufacturer
- Somerset Therapeutics, LLC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 26 Nov 2025
- FDA classified
- 15 Dec 2025
- Reported
- 24 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Nov 2025 | Recall initiated by company | |
| 15 Dec 2025 | Classified by FDA | +19 days |
| 24 Dec 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent product:out of specification assay results observed during long term stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Subpotent product:out of specification assay results observed during long term stability testing.
Which lots are affected?
Lot #: A250020, Exp Date 06/30/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98063This product is part of a recall event; the main page for the event is Cisatracurium Besylate Injection USP, 20 mg/*,(2 mg/mL) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Cisatracurium Besylate Injection USP, 20 mg/*,(2 mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide | |
| CLASS III | Cisatracurium Besylate Injection USP, 10 mg/* (2mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
More recalls from Somerset Therapeutics
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Sodium Phosphate Injection, USP, 100 mg recalledDexamethasone Sodium Phosphate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 10 mg/* (2mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 20 mg/*,(2 mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Atropine Sulfate Ophthalmic Solution recalled by Somerset TherapeuticsAtropine Sulfate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Haloperidol decanoate Injection 50mg/mL recalledHaloperidol Decanoate | Somerset Therapeutics | Foreign Material | Nationwide |
Other Cisatracurium recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 10 mg/* (2mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 20 mg/*,(2 mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS I | Cisatracurium Besylate Injection, USP, 10mg recalledCisatracurium Besylate | Meitheal Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS II | Cisatracurium Besylate Injection, 20 mg per (2 mg per mL) recalledCisatracurium | Fresenius Kabi USA | Labeling Errors | Nationwide |