Recall: D-0117-2025

Class III - Minor Violations

Class IIIClassification

2024-11-22Initiated

OngoingStatus

Dr. Reddy's Laboratories, Inc.Firm

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

Failed Impurities/Degradation Specifications

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.