The Recall Desk
ModerateFDA (Food)·F-0322-2023·Announced 2023-02-08

Inositol dietary supplement recalled due to undeclared niacin

Professional Complementary Health Formulas is recalling Inositol dietary supplement (Lot 1032526, UPC 4065111562) distributed in NY, OR, PA, UT, WI, and WY due to undeclared niacin. Consumers should stop using the product.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for a labeling error involving an undeclared ingredient. No illnesses or injuries have been reported. The hazard is the presence of undeclared niacin, a known substance rather than a high-risk pathogen. This meets the criteria for Score 2 (Moderate): minor labeling error without reported harm.

Plain-English summary

Professional Complementary Health Formulas, LLC is recalling Inositol dietary supplement sold in white plastic bottles. The affected product contains 360 capsules per bottle with UPC 4065111562 and is identified by Lot 1032526. Each capsule is labeled as containing 920 mg of Inositol.

The product is being recalled because it contains undeclared niacin. The product label does not disclose the presence of this ingredient.

The affected Inositol supplement was distributed to consumers in New York, Oregon, Pennsylvania, Utah, Wisconsin, and Wyoming.

Consumers who have purchased this product should stop using it and consult with their healthcare professional if they have questions or health concerns.

The recalled product

Product
Inositol packaged in white plastic bottle with UPC 4065111562 and labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Inositol DIETARY SUPPLEMENT 360 Capsules***Supplement Facts Serving Size: One Capsule***Inositol 920 mg***Other Ingredients: Vegetarian capsule (hypro
Manufacturer
Professional Complementary Health Formulas, LLC
Hazard
  • undeclared-ingredient
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 1032526

Distribution

Distributed nationwide across the United States.