Somerset Therapeutics LLC is recalling approximately 5,870 bottles of Atropine Sulfate Ophthalmic Solution (USP 1%, 5 mL). This voluntary recall was issued because the product failed to meet quality specifications for impurities and degradation during testing. This prescription medication is primarily used to dilate the pupil or treat inflammatory conditions of the eye.
The failure to meet impurities and degradation specifications means the medication may contain substances formed as the drug breaks down, which can reduce the treatment's effectiveness or cause unexpected side effects. While the manufacturer considers the risk level to be low, using degraded medication may compromise patient care.
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Recall #: D-0169-2025; Quantity affected: 5,870 bottles
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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