Elite Laboratories Inc. is recalling 1,264 bottles of Isradapine Capsules USP 2.5 mg because the medication failed to meet quality specifications for impurities and degradation. This recall affects 100-count bottles of the prescription blood pressure medication that were distributed only in New York. While no injuries or adverse effects have been reported, consumers should check their prescription bottles immediately to see if they have the affected lot.
The medication has failed stability testing for impurities, meaning the chemical composition of the drug may have changed over time. This can reduce the effectiveness of the treatment or potentially expose the patient to unintended degradation byproducts.
Contact healthcare provider and return product to pharmacy.
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 ยท 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.