# FDA recall D-0236-2026

> **SOMERSET THERAPEUTICS LLC** · Class III · drug recall initiated 2025-11-26.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0236-2026
- **Recalling firm:** SOMERSET THERAPEUTICS LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-11-26
- **Report date:** 2025-12-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerset, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0236-2026

## Citation

> AI Analytics. FDA recall D-0236-2026. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0236-2026. Source: US FDA. Licensed CC0.

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