Food FDA Class III Terminated Chemical
Prothin, dietary supplement. Seven Packets containing 2 tablets and 4 capsules. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
Preventics, Inc. dba Legere Pharmaceuticals Published Jul 2, 2025
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 47/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Preventics, Inc. dba Legere Pharmaceuticals or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.
Hazards
Allura Red (Red No. 40) · primaryBrillant Blue (Blue No. 1)
Affected products (1)
Prothin, dietary supplement. Seven Packets containing 2 tablets and 4 capsules. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
1696 bags
Code info: 12131
Affected areas
Nationwide
Timeline
- InitiatedApr 30, 2025
- PublishedJul 2, 2025
- TerminatedSep 18, 2025
- Recall number
- H-0091-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA food enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.