Why it was recalled
Failed Impurities/Degradation Specifications
Product description
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0117-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Nov 22, 2024
- FDA report date
- Dec 18, 2024
- Quantity
- 7,233 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0117-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95811
- Address
- 107 College Rd E
- Code information
- 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.
- Postal code
- 08540-6623
- Report date
- Dec 18, 2024
- Product type
- Drugs
- Recall number
- D-0117-2025
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 7,233 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Nov 22, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 12, 2024