Dr. Reddy's Laboratories, Inc. is recalling 7,233 bottles of Javygtor (sapropterin dihydrochloride) Tablets 100mg because the product failed to meet impurity and degradation specifications during testing. Javygtor is a prescription medication used to treat certain conditions, and this recall ensures that only products meeting strict quality standards remain on the market. If you take this medication, you should consult with your healthcare provider or pharmacist about the recall and how to proceed with your treatment.
The failure to meet degradation specifications means the medication may contain higher-than-expected levels of impurities, which can potentially make the drug less effective over time.
You have 2 options:
Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540; Manufactured in India.
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.