The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-0476-2015·Announced 2014-11-19

Maine Natural Health Recalls Pure Whey Protein Supplement for Undeclared Milk

Maine Natural Health, Inc. is recalling Pure Whey Natural Dietary Supplement because the product fails to declare the allergen milk on the label.

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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death due to undeclared allergens.

Plain-English summary

Maine Natural Health, Inc. is recalling Pure Whey Natural Dietary Supplement packaged under the labels Maine Natural Health and Stronger Faster Healthier. The product is packaged in 2 lb (32 oz) and 10 oz containers. The recall involves 4,276 units distributed nationwide.

The recall is being conducted because the product fails to declare the allergen milk on the label. This mislabeling poses a risk to consumers with milk allergies.

Consumers with milk allergies should not consume the product. Individuals who have consumed the product and experienced an allergic reaction should seek medical attention.

The recalled product

Product
Pure Whey Natural Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Packaged in: 2 lb (32 oz), 10 oz
Affected units
4,276

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)

  • All lots codes that the label fails to declare the allergen milk

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Maine Natural Health, Inc. 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.

See all 21 products in this recall →

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