Eli Lilly & Company

Summary

FDA record by year

Eli Lilly & Company's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Eli Lilly & Company above.

Recent recalls

5 recall records from Nov 8, 2018 to Mar 12, 2024.

Recent FDA inspections

36 inspections from Feb 25, 2009 to Jan 9, 2026. Showing the 20 most recent. View all 36 inspections

NAI

No objectionable conditions or practices were found during the inspection.

VAI

Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

OAI

Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 3 compliance actions under Eli Lilly & Company: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 9, 2025.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

3 inspected sites, newest inspection first.

Recent 510(k) clearances

9 510(k) clearances from Sep 25, 1998 to Sep 16, 2022.