Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record. See the Sanofi group view.
As of Nov 13, 2026, FDA's public records list Sanofi and its 29 subsidiaries with 176 drug applications, 113 510(k) clearances, 34 drug recalls, 22 device recalls, 4 complete response letters, 2 warning letters and 2 OPDP letters. The most recent is an OPDP letter dated Jul 15, 2026: Untitled letter: BEYFORTUS.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Sanofi and its 29 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jul 15, 2026 | Untitled letter: BEYFORTUSOffice of Prescription Drug Promotion | OPDP letters |
| Jun 22, 2026 | Warning letter: Data integrity, Cleaning validation, Environmental monitoringCBER | Warning letters |
| Sep 9, 2025 | Untitled letter: TZIELDOffice of Prescription Drug Promotion | OPDP letters |
| Jan 15, 2025 | Warning letter: Aseptic processing, Process validation, Out-of-specificationCDER | Warning letters |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
