The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-1324-2016·Announced 2016-05-18

Health 4 Life Passion 4 Life Recalled for Undeclared Milk and Soy Allergens

Health 4 Life, LLC is recalling Passion 4 Life bottles because they contain undeclared whey protein and soy lecithin, posing a risk to people with 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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Undeclared whey protein containing the allergens of milk and soy lecithin."

Plain-English summary

Health 4 Life, LLC is recalling 8,382 bottles of Passion 4 Life, 30 FL oz. The product is being recalled because it contains undeclared whey protein, which includes the allergen milk, and soy lecithin, which includes the allergen soy.

The affected bottles were distributed nationwide in the United States through online sales. There was no foreign distribution. The specific lot numbers involved are 15093, 15217, 15249, 15248, 15401, 15442, and 16010.

Consumers with allergies to milk or soy should not consume the product. Individuals should check their inventory for the listed lot numbers and dispose of the product or contact the manufacturer for instructions.

The recalled product

Product
Passion 4 Life 30 FL oz. Bottle
Manufacturer
Health 4 Life, LLC
Affected units
8,382

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 (7)

  • Lot #15093
  • 15217
  • 15249
  • 15248
  • 15401
  • 15442
  • 16010

Distribution

Distributed nationwide across the United States.

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