Lupin Pharmaceuticals is recalling 674,628 bottles of Moxifloxacin Ophthalmic Solution USP, 0.5% (3 mL bottles) because the medication failed to meet quality standards for impurities and degradation. This drug is an antibiotic eye drop used to treat bacterial infections; the recall is an expansion of previous actions taken in 2018 and 2019 due to similar out-of-specification results. The affected bottles were distributed nationwide in the USA and Puerto Rico with expiration dates ranging from March 2019 to December 2020.
The product may contain impurities or degradation products at levels higher than the approved safety specifications. While the risk is categorized as low, using a drug that has degraded or contains excessive impurities may reduce the effectiveness of the treatment or cause unforeseen side effects.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a 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
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.