Recalls / Class III
Class IIID-0117-2025
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.
- Brand name
- Javygtor
- Generic name
- Sapropterin Dihydrochloride
- Active ingredient
- Sapropterin Dihydrochloride
- Route
- Oral
- NDC
- 43598-096
- FDA application
- ANDA207685
- Affected lot / code info
- 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.
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddys Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 7,233 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2024-11-22
- FDA classified
- 2024-12-12
- Posted by FDA
- 2024-12-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0117-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.