FDA Drug recall D-0640-2022
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Redd…
- FDA Drug
- Class III
- terminated
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class III recall of Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Redd… by Dr Reddy S Laboratories, citing subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0640-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-02-17 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
Reason
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Identifiers
| code_info | T2100891, Exp. 02/28/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class I · 2025-04-23 · Dr Reddy S Laboratories - Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ…
FDA Drug · Class III · 2024-12-18 · Dr Reddy S Laboratories
All Dr Reddy S Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0640-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.