Warning letterPosted December 15, 2025
FDA warning letter to Walmart, Inc.
Infant Botulism Outbreak
FDA posted a warning letter to Walmart, Inc. on December 15, 2025; the letter is dated December 12, 2025. Subject: Infant Botulism Outbreak. Issuing office: Human Foods Program.
On the record
- Company
- Walmart, Inc.
- Subject
- Infant Botulism Outbreak
- Issuing office
- Human Foods Program
- Letter dated
- 2025-12-12
- Posted by FDA
- 2025-12-15
- Source
- FDA warning letters ↗
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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