FDA Food Recalls

Recalls / Class III

Class IIIH-0091-2025

Product

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)

Type
Food
Affected lot / code info
12131
Quantity
1696 bags

Why it was recalled

Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.

Recalling firm

Firm
Preventics, Inc. dba Legere Pharmaceuticals
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
15344 N 83rd Way Ste 101, Scottsdale, Arizona 85260-2594

Distribution

Distribution pattern
Distributed Nationwide in the United States.

Timeline

Recall initiated
2025-04-30
FDA classified
2025-06-25
Posted by FDA
2025-07-02
Terminated
2025-09-18
Status
Terminated

Source: openFDA Food Enforcement endpoint. Recall record H-0091-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings.