Javygtor — Class III drug recall D-0117-2025
Ongoing recall by Dr. Reddy's Laboratories, Inc., reported 2024-12-18, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0117-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2024-11-22 |
| Classified | 2024-12-12 |
| Reported by FDA | 2024-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 7,233 bottles |
| Reason classes | specification failure |
| NDC | 43598-0096, 43598-0096-04, 43598-0096-05, 43598-0096-30 |
| Lot numbers | T2300653, T2302026, T2302526, T2303750, T2303956, T2304190, T2304987 |
| Expiration dates | 2025-01-31, 2025-03-31, 2025-05-31, 2025-06-30, 2025-08-31 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0117-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.