Soul Nutrition Focus Capsules Recalled for Undeclared Milk
NutraCap Labs LLC is recalling Soul Nutrition Focus unlabeled capsules because the product contains undeclared milk, which poses a risk to consumers with milk allergies.
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. Under the severity rubric, FDA Class I recalls that do not involve reported deaths or serious injury warrant a Severe (4) classification, as allergen mislabeling on common allergens (milk) presents significant risk of harm to allergic consumers.
Plain-English summary
NutraCap Labs LLC is recalling Soul Nutrition Focus unlabeled capsules (90 count bottles) due to the presence of undeclared milk in the product. During an FDA investigation, the firm was notified that the product contains undeclared milk.
The affected product is Lot #2109148 with an expiration date of 09/2023. Approximately 80,169 various 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.
Consumers with milk allergies who have purchased this product should not consume it. Consumers who have this product should discontinue use and consult a healthcare provider if they have experienced any adverse reactions.
The recalled product
- Product
- Soul Nutrition Focus unlabeled Capsules 90ct Bottle UPC CODE
- 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 # 2109148 EXP DATE 09/2023
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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