Class III

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

SOMERSET THERAPEUTICS LLC · December 16, 2024

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

5,870 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0169-2025

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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