Javygtor (sapropterin dihydrochloride) Tablets 100mg recall
FDA recall D-0117-2025 · initiated Nov 22, 2024
Dr. Reddy's Laboratories, Inc. recalled Javygtor (sapropterin dihydrochloride) Tablets 100mg in Nov 2024 — an FDA Class III recall (D-0117-2025) because Failed Impurities/Degradation Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 7,233 bottles
Details
- 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.
- Recalling company
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Nov 22, 2024
- FDA report date
- Dec 18, 2024
Frequently asked
- Was Javygtor (sapropterin dihydrochloride) Tablets 100mg recalled?
- Dr. Reddy's Laboratories, Inc. recalled Javygtor (sapropterin dihydrochloride) Tablets 100mg in Nov 2024 — an FDA Class III recall (D-0117-2025) because Failed Impurities/Degradation Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Javygtor (sapropterin dihydrochloride) Tablets 100mg recalled?
- Per the FDA enforcement record, the reason for recall D-0117-2025 was: Failed Impurities/Degradation Specifications
- Is a recalled Javygtor (sapropterin dihydrochloride) Tablets 100mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Javygtor (sapropterin dihydrochloride) Tablets 100mg are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot #: 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0117-2025.