Super ProTHIN Plus, dietary supplement. Seven Packets with 2 tablets & 4 Capsules and 1 packet with 14 Nutrilean capsul
Summary
The FDA issued a Class III for Super ProTHIN Plus, dietary supplement. Seven Packets with 2 tablets & 4 Capsul by Preventics, Inc. dba Legere Pharmaceuticals. Reason: Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules..
Details
Source
Food Recall
External ID
H-0092-2025
Action Date
2025-07-02
Status
Terminated
Category
food
Product Description
Super ProTHIN Plus, dietary supplement. Seven Packets with 2 tablets & 4 Capsules and 1 packet with 14 Nutrilean capsules. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
Lot/Code Info: 12131
Quantity Affected: 55,080 pills
Reason for Recall
Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.
Distribution
Distributed Nationwide in the United States.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-30
Company
Scottsdale, AZ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 69 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Preventics, Inc. dba Legere Pharmaceuticals has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Preventics, Inc. dba Legere Pharmaceuticals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Preventics, Inc. dba Legere Pharmaceuticals have FDA actions?
Preventics, Inc. dba Legere Pharmaceuticals has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0092-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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