Kenzen Calcium Complex Recalled for Missing Milk Allergen Labeling
HP Ingredients is recalling Kenzen Calcium Complex tablets because the label lacks the required 'Contains: milk' advisory.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
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: The recall is classified as FDA Class III, which indicates a remote probability of adverse health consequences. The hazard is a labeling error regarding a common allergen (milk) without reported illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
HP Ingredients is recalling NIKKENWELLNESS KENZEN brand Calcium Complex Dietary Supplement, 60 Tablets. The recall involves 4,400 bottles of the product. The product was manufactured and distributed to the multi-level marketing firm NIKKEN WELLNESS.
The recall is being conducted because the product label does not bear a "Contains: milk" advisory in the correct format. The label currently reads "Contains ingredients derived from dairy" under the Recommended Use section, which does not meet the specific formatting requirements for major allergen labeling.
Consumers who have purchased this product should check their labels for the specific advisory format. The source text does not provide specific instructions on whether to return the product or dispose of it, nor does it list specific lot numbers or expiration dates in the narrative, though codes are listed in the structured data.
The recalled product
- Product
- NIKKENWELLNESS KENZEN brand Calcium Complex Dietary Supplement 60 Tablets. Label reads "Contains ingredients derived from dairy" under Recommended Use.
- Manufacturer
- HP Ingredients
- 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 (6)
- 10135903
- 9417805
- 9407804
- 9335803
- 9203802
- 8813708
Distribution
Distribution scope not specified by the agency.
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