FDA Drug Recalls

Recalls / Active ingredient / Sapropterin Dihydrochloride

Sapropterin Dihydrochloride

2 FDA drug recalls involving the active ingredient “Sapropterin Dihydrochloride1 Class I.

DateClassProductFirm
2024-11-22Class IIIJavygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's LaboDr. Reddy's Laboratories, Inc.
2024-04-08Class IJavygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx OnDr. Reddy's Laboratories, Inc.