# FDA recall D-0237-2026

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

## Product

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.

## 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-0237-2026
- **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-0237-2026

## Citation

> AI Analytics. FDA recall D-0237-2026. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0237-2026. Source: US FDA. Licensed CC0.

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