Class IIIReported 2024-12-18

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.

Recalled by Dr. Reddy's Laboratories, Inc.

Reason for Recall

Failed Impurities/Degradation Specifications

Recall Number

D-0117-2025

Classification

Class III

Status

Ongoing

Category

drug

Initiated

2024-11-22

Reported

2024-12-18

Distribution

U.S. Nationwide

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.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.