The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-1404-2016·Announced 2016-06-08

Pronutri Tropical Orange Dietary Supplement Recalled for Undeclared Allergens

Pronutri, LLC is recalling 356 bottles of Re-VITA-lize Tropical Orange Dietary Supplement due to undeclared milk and soy lecithin.

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 severity score of at least 4 according to the rubric.

Plain-English summary

Pronutri, LLC is recalling 356 bottles of Pronutri Re-VITA-lize Tropical Orange Dietary Supplement, 32 oz. The recall is due to the presence of undeclared whey protein, which contains the allergens milk and soy lecithin.

The affected product is identified by Lot #15554. The product was distributed in the United States to California, Texas, Oregon, Iowa, Minnesota, and Colorado. There is no foreign distribution.

Consumers with a milk or soy allergy should avoid consuming this product. Individuals who have consumed the product and are experiencing symptoms should contact a healthcare provider.

The recalled product

Product
Pronutri Re-VITA-lize Tropical Orange Dietary Supplement 32 oz.
Manufacturer
Pronutri, LLC
Affected units
356

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 #15554

Distribution

Distributed in 6 states:

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