Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Javygtor (sapropterin dihydrochloride) Tablets 100mg Recalled by Dr. Reddy's Laboratories, Inc. Due to Failed Impurities/Degradation Specifications
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Dr. Reddy's Laboratories, Inc. directly.
Affected Products
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.
Quantity: 7,233 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Dr. Reddy's Laboratories, Inc.
Dr. Reddy's Laboratories, Inc. has 163 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report