Lupin Pharmaceuticals Inc. is recalling 9,930 bottles of Bimatoprost Ophthalmic Solution 0.03% (a prescription eye drop) because testing revealed individual and total impurities that exceeded safety specifications. These eye drops were sold in 5 mL and 7.5 mL sizes across the United States. While no specific injuries were reported in the recall notice, the presence of unidentified impurities or chemical degradation in a medication meant for the eye can lead to ineffective treatment or unexpected reactions.
The product failed stability testing due to out-of-specification results for chemical impurities and degradation, which means the medication may not be pure or potent as intended. Using a drug that has degraded or contains unknown impurities could potentially cause irritation or fail to provide the intended medical benefit for the patient.
Pharmacy refund and healthcare consultation
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.