# FDA recall D-0354-2025

> **Somerset Therapeutics Private Limited** · Class II · drug recall initiated 2025-03-21.

## Product

Methocarbamol Injection USP	1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)

## Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0354-2025
- **Recalling firm:** Somerset Therapeutics Private Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-21
- **Report date:** 2025-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bengaluru, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0354-2025

## Citation

> AI Analytics. FDA recall D-0354-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0354-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*