Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg recall
FDA recall D-0485-2024 · initiated Apr 8, 2024
Dr. Reddy's Laboratories, Inc. recalled Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg in Apr 2024 — an FDA Class I recall (D-0485-2024) because Sub-potent Drug; powder discoloration associated with decreased potency.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Sub-potent Drug; powder discoloration associated with decreased potency
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 17,332 cartons
Details
- Product
- Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.
- Recalling company
- Dr. Reddy's Laboratories Limited
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 8, 2024
- FDA report date
- May 15, 2024
Frequently asked
- Was Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg recalled?
- Dr. Reddy's Laboratories, Inc. recalled Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg in Apr 2024 — an FDA Class I recall (D-0485-2024) because Sub-potent Drug; powder discoloration associated with decreased potency. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg recalled?
- Per the FDA enforcement record, the reason for recall D-0485-2024 was: Sub-potent Drug; powder discoloration associated with decreased potency
- Is a recalled Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 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. Most serious — a reasonable probability that use will cause serious harm or death. 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) Powder for Oral Solution 100mg are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.. 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-0485-2024.