Teva Pharmaceuticals is recalling approximately 1,157,095 bottles of Fluoxetine Tablets (the generic version of Prozac) because routine testing found the presence of a lactoside impurity that exceeded safety specifications. This recall includes all lots that have not yet expired for the 10 mg strength sold in 30-count bottles. Consumers should check their medication bottles immediately for the NDC code 0093-7188-56 to see if their supply is affected.
The recall was initiated after routine stability testing showed an out-of-specification result for a lactoside impurity, which is a degradation product that may compromise the drug's quality standards over time.
Healthcare 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
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.