FDA Drugs recall ·
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only… recall
- Recall number
- D-0169-2025
- Date
- (initiated December 16, 2024)
- Company / brand
- Somerset Therapeutics LLC
300 Franklin Square Dr, Somerset, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Terminated
- Units affected
- 5,870 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
Why was it recalled?
Failed Impurities/Degradation Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: A240211, Exp. Date April 2026
Distribution
Nationwide within the United States
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0169-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.