New Generation Wellness Inc. Recall: Vitamin D3 stability sample analyzed and found to be less than 100% of label claim. - F-0385-2021

🇺🇸 United States

1. March 8, 2021 - Recall initiated
2. April 14, 2021 - Reported by source
3. April 22, 2022 - Recall terminated

Official source record

Agency

FDA

Dataset

FDA Food Enforcement (Recalls)

Recall number

F-0385-2021

Event ID

87451

Status

Terminated

Classification

Class III

Company

New Generation Wellness Inc.

Product description

VEGAN VITAMIN D3, 50 mcg (2,000 IU), 60 VEGAN TABLETS in 100cc amber glass bottles. UPC 7 19985 61831 4; UPC 6 10265 58337 0; UPC 4 01008 61831 8; UPC 4 02008 61831 5. Store in a cool, dry place. Product is sold under 72 private labels: A Moveable Feast; Akin's Natural Foods; Arbor Farms Market; Ashland Food Co-op; Bath Natural Market; Berkshire Food Co-op; Betsy's Basics; Bloomingfoods; Boney's Bayside Market; Cambridge Naturals; Campbell's Nutrition; Central Co-op; Chamberlin's; Community Food Co-op; Cornucopia Natural Wellness Market (MA); Cream of the Crop; Dawson's Market; Debra's Natural Gourmet; Dr. Bar's; Ellwood Thompson's; Everything Natural; First Alternative Natural Foods Co-op; Flatbush Food Co-op; Frazier Farms; Good Earth Natural Food Company; Good Foods Grocery; GreenStar Food Co-op; Guido's Fresh Marketplace; Harmony Co-op; Healthy Living (TX); The Herb Shop of Vining's; Lakeshore Natural Foods; Lassens Natural Foods & Vitamins; Linden Hills Co-op; Lori's Natural Foods Center; LSV LifeSource Vitamins; Mama Jean's Natural Market; Mari Mann Herb Co., Inc.; Marquette Food Co-op; Mississippi Market Natural Foods Co-op; Mike's Choice; MOM's Organic Market; Mother's Market & Kitchen; Mustard Seed Market & Cafe; Natural Harvest Food Co-op; New Morning Market; New Pioneer Food Co-op; Olympia Food Co-op; Oryana Natural Foods Market; Outpost Natural Foods; People's Food Co-op; Ramona Family Naturals Market; Red Fox Market; River Market Community Co-op; Roots Market; Seaside Market; Skagit Valley Food Co-op; South River Compounding Pharmacy; St. Patrick's Nutritional Supplements, Inc.; Saint Peter Food Co-op; Sugar Beet Food Co-op; The Cornucopia Natural Foods Market (TX); Valley Natural Foods; Vitamer; Weaver Street Market; Wedge Community Co-op; Wheatsfield Co-op; Whole Family Nutrition & Market; Whole Foods Co-op; The Whole Wheatery; Wild By Nature; Wild Oats Market; Windmill Farms.

Quantity

2330 bottles

Reason

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

Recall initiation date

March 8, 2021

Report date

April 14, 2021

Classification date

Not published in this source record

Termination date

April 22, 2022

Distribution pattern

Nationwide.

UPC, lot, and code information

Product code VVL 618-60C (618 is product, -60C is 60 count) Lot number: 004546, exp. 05/22

Voluntary or mandated

Voluntary: Firm initiated

Initial notification method

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Source last updated

Not tracked separately from the Public Health Trace retrieval date below

Public Health Trace retrieval date

July 18, 2026 ET

Other products recalled under this same event

This recall shares FDA event ID 87451 with 1 other product entry in Public Health Trace.

Responsible company: New Generation Wellness Inc.

Other recalls from New Generation Wellness Inc.

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.

New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace: July 18, 2026 ET

Frequently asked questions

What does a Class III mean?

FDA classifies this recall as Class III. See how to read an FDA recall record (linked above) for what each classification level means.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the responsible agency's published instructions, linked below -- recall guidance is set by that agency, not by Public Health Trace.

Official guidance and record verification

Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.

How to interpret this historical record

This record is preserved as published by FDA, as of April 22, 2022.

Status as reported: Terminated.

This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.

View the official FDA source

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

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