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Food FDA Class III Terminated Chemical

Protrim Plus, dietary supplement. 90 capsule/bottles. 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 III

Unlikely 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)

Protrim Plus, dietary supplement. 90 capsule/bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)

763 Containers

Code info: 21634-9

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 30, 2025
  2. Published
    Jul 2, 2025
  3. Terminated
    Sep 18, 2025
Recall number
H-0093-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

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.