FDA Drug recall D-0486-2024
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratorie…
- FDA Drug
- Class I
- ongoing
- Published 2024-05-15
On 2024-05-15 the FDA classified a Class I recall of Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratorie… 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-0486-2024 |
| 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
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 43598-477-30.
Reason
Sub-potent Drug; powder discoloration associated with decreased potency
Identifiers
| code_info | Lot # T2200352, Exp. 12/31/2024 |
|---|
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-0486-2024%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.