FDA Drug recall D-0059-2023
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aa…
- FDA Drug
- Class III
- terminated
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class III recall of Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aa… by Aadi Bioscience, citing failed Stability Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0059-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-10-13 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aadi Bioscience |
| Distribution | AL, KY, PA, TN |
Product
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.
Reason
Failed Stability Specifications
Identifiers
| ndc | 80803-153-50 |
|---|---|
| code_info | Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0059-2023%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.