# FDA recall D-0169-2025

> **SOMERSET THERAPEUTICS LLC** · Class III · drug recall initiated 2024-12-16.

## Product

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0169-2025
- **Recalling firm:** SOMERSET THERAPEUTICS LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-12-16
- **Report date:** 2025-01-08
- **Termination date:** 2025-06-10

- **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-0169-2025

## Citation

> AI Analytics. FDA recall D-0169-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0169-2025. Source: US FDA. Licensed CC0.

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