Class III · Lower riskActive recall
Javygtor
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: 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 soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byMade in India foreign manufacturer
| Brand name | JAVYGTOR |
| Generic name | SAPROPTERIN DIHYDROCHLORIDE |
| Active ingredient(s) | SAPROPTERIN DIHYDROCHLORIDE |
| Distributed by / for | Dr. Reddy's Laboratories, Inc. |
| NDC | 43598-096-04 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Distribution | U.S. Nationwide |
| Quantity | 7,233 bottles |
| Recall initiated | 2024-11-22 |
| Report date | 2024-12-18 |
| Recall completed | — |
| Recall number | D-0117-2025 |
| Classification | Class III |
| FDA status | Ongoing |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.