Fyarro — Class III drug recall D-0059-2023
Terminated recall by Aadi Bioscience, reported 2022-11-23, distributed in AL, KY, PA, TN. Failed Stability Specifications
| Recall number | D-0059-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aadi Bioscience, Pacific Palisades, CA, United States |
| Recall initiated | 2022-10-13 |
| Classified | 2022-11-14 |
| Reported by FDA | 2022-11-23 |
| Terminated | 2023-03-16 |
| Distributed | AL, KY, PA, TN |
| Quantity | 2,333 vials |
| Reason classes | specification failure |
| NDC | 80803-0153-50 |
| Lot numbers | 100MG/VIAL, 6025701 |
| Expiration dates | 2023-03-31 |
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 for recall
Failed Stability Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0059-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.