Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Atropine Sulfate Ophthalmic Solution Recalled by SOMERSET THERAPEUTICS LLC Due to Failed Impurities/Degradation Specifications

Date: December 16, 2024
Company: SOMERSET THERAPEUTICS LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SOMERSET THERAPEUTICS LLC directly.

Affected Products

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

Quantity: 5,870 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SOMERSET THERAPEUTICS LLC

SOMERSET THERAPEUTICS LLC has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report