Recall D-0117-2025

US Class III Ongoing · initiated 2024-11-22

Recalling firm

Dr. Reddy's Laboratories, Inc., NJ

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

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