Dr. Reddy's Laboratories, Inc. recalls Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories I
Recalled December 18, 2024 · FDA recall D-0117-2025 · Dr. Reddy's Laboratories
Hazard
Failed Impurities/Degradation Specifications · FDA Class III
Units
7,233 bottles
Sold at
U.S. Nationwide
Description
Failed Impurities/Degradation Specifications
Product
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.
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →