Javygtor Tablets 100mg (Dr. Reddy's) – Impurity Specifications (2024)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Dr. Reddy's Laboratories, Inc.
Lot Codes / Batch 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.
Products Sold
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.
Dr. Reddy's Laboratories, Inc. is recalling Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Re due to Failed Impurities/Degradation Specifications. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 7, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.