FDA recall D-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.

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

U.S. Nationwide

Key facts

Status

Ongoing

Initiation date

2024-11-22

Report date

2024-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0117-2025