Bausch & Lomb has recalled approximately 170,832 bottles of Lotemax (loteprednol etabonate ophthalmic gel 0.5%), a sterile prescription eye medication. The recall was initiated because the product failed stability testing due to being out of specification for viscosity, which can affect how the gel is dispensed or how it performs. If you use this medication, contact your healthcare provider or pharmacist for guidance regarding your treatment.
The gel's viscosity (thickness) does not meet required quality standards, which may impact the consistency and delivery of the medication to the eye. While the risk level is considered low, consistent viscosity is necessary to ensure the drug performs as intended throughout its shelf life.
Healthcare provider consultation and pharmacy refund.
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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