Pure Herbs Protein Extract Recalled for Undeclared Milk and Soy Allergens
Pure Herbs, Ltd. is recalling Natural Herbal Extracts Protein Dietary Supplement bottles because they contain undeclared milk and soy allergens, posing a risk of serious allergic reactions.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death, meeting the criteria for a Severe rating.
Plain-English summary
Pure Herbs, Ltd. is recalling its Natural Herbal Extracts Protein Dietary Supplement, available in 120mL (4 fl. oz.) and 30mL (1 fl. oz.) bottles. The recall involves 813 four-ounce bottles and 72 one-ounce bottles. The product is being recalled because it contains undeclared milk and soy allergens.
The affected products were sold to a network of independent distributors and consumers. The recall covers lot codes 243 and 050812, 012712A, as well as all protein products manufactured prior to lot 243. The manufacturer does not have records indicating the specific lot numbers for products manufactured before lot 243.
People with an allergy or severe sensitivity to milk or soy are at risk of a serious or life-threatening allergic reaction if they consume this product. Consumers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Pure Herbs, Ltd. Natural Herbal Extracts Protein Dietary Supplement.120mL/4 fl. oz. bottle; 30mL/1 fl.oz bottle.
- Manufacturer
- Pure Herbs Ltd
- Category
- Food — Dietary Supplement
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)
- Lot codes being recalled are lots 243 and 050812
Distribution
Distribution scope not specified by the agency.
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