FDA Drugs recall ·
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle… recall
- Recall number
- D-0117-2025
- Date
- (initiated November 22, 2024)
- Company / brand
- Dr. Reddy's Laboratories, Inc.
107 College Rd E, Princeton, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 7,233 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Impurities/Degradation Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
U.S. Nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0117-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.