Dietary Supplement Recall Update As FDA Sets Risk Level
A vitamin B supplement currently being recalled in the U.S. and Canada due to incorrect formulation has been given a moderate to high risk level by the Food and Drug Administration (FDA).
On October 7, Nestle Health Science issued a voluntary recall for Douglas Labs Stress-B-Plus Dietary Supplement Tablets. The products were incorrectly formulated with niacin instead of niacinamide.
Niacin can cause a flushing reaction that can lead to burning, itching or redness on the face, arms or chest. This reaction is usually temporary and goes away as the body gets used to the vitamin.
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On November 17, the FDA issued a Class II risk classification for the affected supplements.
Stock image of vitamin B12 pills. The FDA has classified a dietary supplement recall as Class II.
Justin Sullivan/Getty Images
A Class II rating means there is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
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Nestle approximates that 3,269 affected bottles are in the market. The lot numbers of the affected batches are 50335944 and 50344396. Each white plastic bottle contains 90 pills and the expiry date for the affected batches is 04/11/2026.
The affected products are distributed to retailers across 37 states—Alaska, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia
There is also a recall for this product in place across Canada.
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Nestle advises that customers who have bought one of the affected batches should contact Nestle Consumer Services on 1-800-225-2270 for reimbursement.
A Nestle health science spokesperson told Newsweek: “At Douglas Laboratories, the health and safety of consumers is our highest priority. Out of an abundance of caution in October, we initiated a voluntary recall of our Stress-B Plus tablets due to the product being manufactured with Niacin instead of Niacinamide. A common response to Niacin is a temporary flushing reaction that does not pose a safety risk. At this time, the recall has been completed and the affected product has been removed from all markets.”
Vitamin B supplements are used by those who want to supplement their daily diet with B vitamins and related nutrients.
Despite sounding similar, niacin and niacinamide are not the same.
Niacin, also known as nicotinic acid, is a B3 compound made from the amino acid tryptophan. It is found in foods including meat, fish, milk and eggs. In the body, niacin is used to turn food into energy.
As a supplement, niacin can be used to lower cholesterol, ease arthritis and improve brain function.
Niacinamide, a water soluble B3, is a product made from an excess of niacin. It is also found in foods such as meat and eggs and is used to treat vitamin B3 deficiency. It can also be used to help with acne, diabetes and arthritis.
Due to its proactive and hydrating properties, niacinamide is also widely used in skincare products to increase hydration and minimize the appearance of pores.
Correctly manufactured Douglas Labs Stress-B-Plus Dietary Supplement Tablets should contain 200mg of niacinamide.
Update 11/18/24, 11:05 a.m. ET: This article was updated with comment from Nestle.
