Class III

Drug Recall: Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.

Dr. Reddy's Laboratories, Inc. · November 22, 2024

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution

U.S. Nationwide

States Affected

NATIONWIDE

Quantity Affected

7,233 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0117-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.