SOMERSET THERAPEUTICS LLC: Drug Recall

Recall #D-0169-2025 · 12/16/2024

Class III: Low Risk

Recall Details

Recall Number: D-0169-2025
Classification: Class III
Product Type: Drug
Recalling Firm: SOMERSET THERAPEUTICS LLC
Status: Terminated
Date Initiated: 12/16/2024
Location: Somerset, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,870 bottles

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

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

Distribution Pattern

Nationwide within the United States

Other Recalls by SOMERSET THERAPEUTICS LLC

Class III: Low Risk 11/26/2025

Subpotent product:out of specification assay results observed during long term stability testing.
Class III: Low Risk 11/26/2025

Subpotent product:out of specification assay results observed during long term stability testing.
Class III: Low Risk 11/26/2025

Subpotent product:out of specification assay results observed during long term stability testing.
Class II: Risk 04/24/2024

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

View all recalls by SOMERSET THERAPEUTICS LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.