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.
Class III · Ongoing
Failed Impurities/Degradation Specifications
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Affected lots / codes — check yours against thisLot #: 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.
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Classification
- Class III (unlikely to cause harm)
- Status
- Ongoing
- Quantity
- 7,233 bottles
- Distribution
- U.S. Nationwide
- Recall initiated
- November 22, 2024
- Classified
- December 12, 2024
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0117-2025%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0117-2025%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →