Prothin Dietary Supplement Recall for Undeclared Food Dyes
Preventics, Inc. is recalling Prothin dietary supplement packets because they contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules, which may affect consumers with dye sensitivities or allergies.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving undeclared allergens (food dyes). Class III recalls are by definition unlikely to cause adverse health consequences, and no reported illnesses or injuries are stated in the source. The hazard is labeling-related with theoretical risk to sensitive consumers.
Plain-English summary
Preventics, Inc. dba Legere Pharmaceuticals is recalling Prothin dietary supplement. The product consists of seven packets containing 2 tablets and 4 capsules. According to the FDA, the gelatin capsules contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1), food dyes that are not listed on the product label.
The undeclared dyes pose a risk to consumers who have sensitivities or allergies to these food colorings. Approximately 1,696 bags of this product were distributed nationwide in the United States. The affected product has a code number of 12131.
Consumers who have purchased Prothin should stop using it and consult with a healthcare provider if they have concerns about exposure to these undeclared dyes. For more information, consumers may contact the recalling firm, Preventics, Inc. dba Legere Pharmaceuticals, located at 15344 N 83rd Way, Scottsdale, AZ 85260.
The recalled product
- 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)
- Manufacturer
- Preventics, Inc. dba Legere Pharmaceuticals
- Category
- Food — Dietary Supplement
- Hazard
- allergen-food-dye
- undeclared-ingredient
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 12131
Distribution
Distributed nationwide across the United States.
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