Human Project Big Dreams Capsules Recalled for Undeclared Milk
NutraCap Labs LLC is recalling Human Project Big Dreams Capsules (120ct bottle, UPC 8 60460 00194 4, Lot #2009062) because the product contains undeclared milk, a common allergen that poses a risk to milk-allergic consumers.
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 has classified this as a Class I recall, which mandates a minimum severity score of 4 according to the rubric. Allergen mislabeling on common allergens (milk) without reported illness would otherwise warrant a score of 3, but the Class I classification takes precedence.
Plain-English summary
NutraCap Labs LLC is recalling Human Project Big Dreams Capsules, 120-count bottle (UPC CODE 8 60460 00194 4, Lot #2009062, expiration date 09/2022). During an FDA investigation, the firm was notified that the product contains undeclared milk.
Approximately 80,169 bottles and jars were distributed to the following states: AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MD, MN, NC, NJ, NV, NY, OH, OR, SC, TN, TX, VA, and WA.
Milk is a major allergen. Consumers with milk allergies or intolerance who consume this product may experience allergic reactions ranging from mild to severe.
Consumers who have purchased this product should stop using it. Those with concerns about potential exposure should consult a healthcare provider. Retailers should remove affected product from shelves.
The recalled product
- Product
- Human Project Big Dreams Capsules 120ct Bottle UPC CODE 8 60460 00194 4
- Manufacturer
- NutraCap Labs LLC
- Category
- Food — Dietary Supplement
- Affected units
- 80,169
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 #2009062 EXP DATE 09/2022
Distribution
Part of a larger recall action
This product is one of 106 recalled by NutraCap Labs LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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