Fyarro sirolimus injectable drug recalled due to failed stability specifications
Aadi Bioscience recalls 2,333 vials of Fyarro (sirolimus) injectable suspension distributed to four U.S. states due to failed stability specifications. No illnesses or injuries have been reported.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. Stability failure in a prescription drug warrants precautionary removal from use, but the low agency classification and absence of documented harm justify a moderate rather than high severity level per the rubric for precautionary recalls.
Plain-English summary
Aadi Bioscience is recalling 2,333 vials of Fyarro (sirolimus protein-bound injectable suspension, 100 mg per vial), NDC 80803-153-50, Lot #6025701, expiration date 31 March 2023. The affected product was distributed in Pennsylvania, Alabama, Kentucky, and Tennessee. The recall was initiated due to failed stability specifications.
No illnesses or injuries have been reported in association with this lot. Patients currently taking Fyarro from the affected lot should contact their healthcare provider for guidance. Healthcare facilities and distributors with the affected lot should quarantine the product and return it to Aadi Bioscience for proper handling.
The recalled product
- Product
- FYARRO (SIROLIMUS)
- Brand
- FYARRO
- Manufacturer
- Aadi Bioscience
- Category
- Drug — Immunosuppressant
- Hazard
- Affected units
- 2,333
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot# 6025701
- Expiration Date: 31MAR2023
- 100mg/vial
- 50 ml single use vial
- NDC 80803-153-50.
Distribution
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