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RECALL RECORD — CLASS IRecall closedF-1404-2016/FDA enforcement
Pronutri, LLC·Dietary Supplements·Apr 18, 2016

Pronutri Re-vita-lize Tropical Orange Dietary Supplement 32 OZ

What you need to know

Class I

  • What happened

    Undeclared whey protein which contains the allergens milk and soy lecithin.

  • Health risk

    The product has a reasonable probability of causing serious adverse health consequences or death. An allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

  • Action required

    Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure.

Recall closed · classified by the FDACA, TX, OR, IA +2 moreMore supplements

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Product identification

Source: FDA FOOD

Brand namePronutri, LLC
Recalling firmPronutri, LLCHuntington Beach, CA, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • Lot #15554
Distribution area
CATXORIAMNCO

U.S. distribution to the following; CA, TX, OR, IA, MN, CO No foreign distribution.

United States

Quantity affected356 bottles
Recall initiationFDA report date: June 8, 2016
FDA recall numberF-1404-2016

Beyond the headline

The recall, in context

Pronutri, LLC initiated this supplements recall on April 18, 2016. The FDA enforcement report states: Undeclared whey protein which contains the allergens milk and soy lecithin. The FDA report lists distribution as: U.S. distribution to the following; CA, TX, OR, IA, MN, CO No foreign distribution.

The FDA enforcement report describes the reason as: Undeclared whey protein which contains the allergens milk and soy lecithin.

Pronutri Re-vita-lize Tropical Orange Dietary Supplement 32 OZ was made or distributed by Pronutri, LLC in Huntington Beach, CA, United States. This page reflects FDA report F-1404-2016, dated June 8, 2016.

Why this is a Class I recall

Class I means the product has a reasonable probability of causing serious adverse health consequences or death. In this recall, an allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

FDA definition

The product has a reasonable probability of causing serious adverse health consequences or death.

What to do now

  1. 1

    Stop using it

    Do not eat, drink or take the affected product.

  2. 2

    Check the codes

    Compare the lot and date codes against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Undeclared milk

Symptoms to watch for

Hives, swelling, wheezing, vomiting or anaphylaxis can occur in people with a milk allergy.

When symptoms may appear

Reactions can begin within minutes to a few hours after eating the product.

Higher-risk groups

People with a diagnosed cow's milk allergy, especially children and anyone with a history of anaphylaxis.

What to do now

  1. 1Do not eat the product if you have a milk allergy.
  2. 2Seek emergency care for breathing difficulty, throat swelling or other signs of anaphylaxis.
  3. 3Keep the packaging and contact the retailer or manufacturer about a refund.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Pronutri Re-vita-lize Tropical Orange Dietary Supplement 32 OZ recall?

Pronutri, LLC recalled Pronutri Re-vita-lize Tropical Orange Dietary Supplement 32 OZ in an FDA Class I enforcement action reported as F-1404-2016. Undeclared whey protein which contains the allergens milk and soy lecithin.

What should I do if I bought this product?

Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure. Do not eat the product if you have a milk allergy. Seek emergency care for breathing difficulty, throat swelling or other signs of anaphylaxis. Keep the packaging and contact the retailer or manufacturer about a refund.

Is the Pronutri, LLC recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record F-1404-2016. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.