FDAFDA · Food and drugs·Recall number D-0117-2025
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.
Published December 18, 2024 · Recall initiated: November 22, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- JAVYGTOR
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- U.S. Nationwide
- UPC
- 0343598096049
- Lot
- Lot #: T2300653, Exp 01/31/2025; T2303956, T2303750, Exp 06/30/2025; T2304190, T2304987, Exp 08/31/2025; T2302026, Exp 03/31/2025; T2302526, Exp 05/31/2025.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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