FDA Drug recall D-0485-2024
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's…
- FDA Drug
- Class I
- ongoing
- Published 2024-05-15
On 2024-05-15 the FDA classified a Class I recall of Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's… by Dr Reddy S Laboratories, citing sub-potent Drug; powder discoloration associated with decreased potency.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0485-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-04-08 |
| Published | 2024-05-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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.
Reason
Sub-potent Drug; powder discoloration associated with decreased potency
Identifiers
| ndc | 43598-097-11 |
|---|---|
| ndc | 43598-097-30 |
| code_info | Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0485-2024%22
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