United States: A specific Vitamin B supplement marketed in the United States and Canada has recently been flagged for its improper composition, prompting a recall. The US Food and Drug Administration (FDA) has categorized the associated risk as moderate to high, emphasizing the significance of the formulation issue.
Recall Announcement and Root Cause
On October 7, Nestlé Health Science initiated a voluntary withdrawal of its Douglas Labs Stress-B-Plus Dietary Supplement Tablets. The issue arose from an incorrect substitution of niacinamide with niacin in the product’s formulation, according to Newsweek.
Unlike niacinamide, niacin can incite a phenomenon known as flushing, characterized by transient sensations of warmth, irritation, or redness, primarily affecting the facial area, upper arms, or chest. This reaction, although fleeting, can be disconcerting until the body adapts to the vitamin’s presence.
FDA Classification and Product Impact
The FDA officially designated the recall as a Class II risk on November 17. Such a classification indicates scenarios where the consumption or exposure to a problematic product may result in short-term or medically reversible health consequences, with severe outcomes being improbable.
Nestlé estimates that approximately 3,269 bottles of the affected supplement remain in circulation. These compromised batches—identified by lot numbers 50335944 and 50344396—are housed in white plastic containers, each comprising 90 tablets, and bear an expiration date of April 11, 2026, as reported by Newsweek.
Geographic Distribution and Consumer Advisory
The defective supplements have been disseminated to retailers across 37 US states, including Alaska, Arizona, California, Colorado, and Texas, among others. The recall extends to Canadian markets as well.
Consumers in possession of the implicated products are urged to contact Nestlé Consumer Services at 1-800-225-2270 to request a reimbursement.
Official Statement and Consumer Reassurance
A spokesperson for Nestlé Health Science conveyed to Newsweek:
“At Douglas Laboratories, consumer well-being remains our paramount concern. Acting out of an abundance of caution, we enacted a voluntary recall in October upon discovering that our Stress-B-Plus tablets were produced with niacin instead of niacinamide. Niacin’s flushing effect, though transient and non-hazardous, necessitated this precautionary measure. The recall has since concluded, and the impacted products have been completely removed from the market.”
Distinction Between Niacin and Niacinamide
While niacin and niacinamide are both derivatives of Vitamin B3, their functionalities and applications diverge.
Niacin, also called nicotinic acid, is a B3 compound synthesized from the amino acid tryptophan and is naturally present in meat, fish, dairy, and eggs. It plays a critical role in converting food into energy and is often employed to reduce cholesterol, alleviate arthritis symptoms, and support cognitive health.
Niacinamide, a water-soluble form of B3 derived from surplus niacin, is also found in protein-rich foods. It is utilized to combat Vitamin B3 deficiency and is acclaimed for its therapeutic benefits in managing acne, diabetes, and arthritis. Additionally, its hydrating properties render it a staple in skincare formulations aimed at refining skin texture and minimizing pore visibility, according to Newsweek.
Correct Formulation of Stress-B-Plus Tablets
Properly produced Douglas Labs Stress-B-Plus Dietary Supplement Tablets are formulated to contain 200 mg of niacinamide, ensuring efficacy and safety for consumers seeking to bolster their dietary intake of Vitamin B.