2025-24155Notice

FDA Finally Revokes Emergency COVID-Flu Tests from Pfizer Era

Published Date: 1/2/2026

Notice

Summary

The FDA has officially ended the emergency use of two COVID-19 and flu tests made by Pfizer, effective October 22, 2025. This change affects anyone using these specific tests, as they’re no longer authorized for emergency use. No extra costs or deadlines for the public, but labs and providers should switch to other approved tests.

Analyzed Economic Effects

1 provisions identified: 0 benefits, 1 costs, 0 mixed.

Pfizer Lucira Tests EUA Revoked

The FDA revoked the Emergency Use Authorizations (EUAs) for two tests: the Lucira by Pfizer COVID-19 & Flu Test and the Lucira by Pfizer COVID-19 & Flu Home Test. The revocations were effective October 22, 2025; Pfizer requested the revocations on October 10, 2025 and told FDA there were no viable test reagents remaining in the United States.

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Key Dates

Effective Date
Published Date
10/22/2025
1/2/2026

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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