KAL Amino Acid Complex Recalled for Undeclared Milk Allergen
Nutraceutical International is recalling KAL Amino Acid Complex because the ingredient list does not explicitly state 'milk,' despite containing casein.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves allergen mislabeling on a common allergen (milk/casein), which corresponds to a severity score of 3 (High) per the rubric.
Plain-English summary
Nutraceutical International Corporation is recalling KAL Brand Amino Acid Complex, Product #51610, due to an undeclared allergen. The product contains casein, which is a disclosed ingredient, but the word 'milk' is not specifically noted on the ingredient list. This labeling omission presents a risk to consumers with milk allergies.
The recall affects 9,501 bottles of the product. The affected items are identified by UPC 021245516101 and Product #51610. All lots with Use By Dates prior to January 2019 are included in the recall. The product was distributed nationwide to 34 states, with no distribution to foreign, VA, government, or military channels.
Consumers with milk allergies should avoid using the product. Those who have purchased the affected items should check their Use By Dates and UPC codes to determine if they are part of the recall. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- KAL Brand Amino Acid Complex UPC 021245 51610 1, Product #51610
- Manufacturer
- Nutraceutical International Corporation
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 9,501
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 (3)
- UPC 021245516101
- Product #51610
- All lots with Use By Dates prior to January 2019.
Distribution
Distributed nationwide across the United States.
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