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RECALL RECORD — CLASS IIIRecall closedF-0385-2021/FDA enforcement
New Generation Wellness INC.·Dietary Supplements·Mar 8, 2021

Vegan Vitamin D3, 50 Mcg (2, 000 Iu), 60 Vegan Tablets in 100cc Amber Glass Bottles

What you need to know

Class III

  • What happened

    Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.

  • Health risk

    The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. A safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

  • 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 FDANationwide (US)More supplements

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Product identification

Source: FDA FOOD

Brand nameNew Generation Wellness INC.
Recalling firmNew Generation Wellness INC.Colorado Springs, CO, United States
UPC / barcodes
7 19985 61831 46 10265 58337 04 01008 61831 84 02008 61831 5
Lot / date codes
  • Product code VVL 618-60C (618 is product, -60C is 60 count) Lot number: 004546, exp. 05/22
Distribution area
Nationwide

Nationwide.

United States

Quantity affected2330 bottles
Recall initiationFDA report date: April 14, 2021
FDA recall numberF-0385-2021

Beyond the headline

The recall, in context

New Generation Wellness INC. initiated this supplements recall on March 8, 2021. The FDA enforcement report states: Vitamin D3 stability sample analyzed and found to be less than 100% of label claim. The FDA report lists distribution as: Nationwide.

The FDA enforcement report describes the reason as: Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.

Vegan Vitamin D3, 50 Mcg (2, 000 Iu), 60 Vegan Tablets in 100cc Amber Glass Bottles was made or distributed by New Generation Wellness INC. in Colorado Springs, CO, United States. This page reflects FDA report F-0385-2021, dated April 14, 2021.

Why this is a Class III recall

Class III means the product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. In this recall, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

FDA definition

The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations.

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 UPC and lot code 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

Product safety recall

Symptoms to watch for

The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.

Higher-risk groups

Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.

What to do now

  1. 1Stop using or eating the product and keep it away from children and pets.
  2. 2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
  3. 3Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Read the official source record for the specific hazard and instructions.

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 Vegan Vitamin D3, 50 Mcg (2, 000 Iu), 60 Vegan Tablets in 100cc Amber Glass Bottles recall?

New Generation Wellness INC. recalled Vegan Vitamin D3, 50 Mcg (2, 000 Iu), 60 Vegan Tablets in 100cc Amber Glass Bottles in an FDA Class III enforcement action reported as F-0385-2021. Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.

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. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Is the New Generation Wellness INC. 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-0385-2021. 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

Brand history

More recalls by New Generation Wellness INC.

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