FDA Issues Recall for Chewable Multivitamins in 25 States

A voluntary recall has been issued for a chewable multivitamin distributed in 25 states due to lower-than-intended levels of vitamin D, according to the U.S. Food and Drug Administration (FDA). The affected product is the Multivitamin with Fluoride Chewable Tablets, grape flavor, manufactured by Winder Laboratories, LLC, based in Winder, Georgia.

The recall affects two versions of the multivitamin. One version contains 0.25 mg of fluoride and is packaged in bottles of 100 tablets with the National Drug Code (NDC) 75826-169-10. The second version includes 1.0 mg of fluoride, also sold in 100-tablet bottles, with NDC 75826-171-10.

The recall was initiated following an inspection by the FDA that revealed the products were subpotent for vitamin D, meaning they contained less of the vitamin than intended. Vitamin D is crucial for bone health, as it aids in calcium absorption and supports the immune system. Insufficient levels of vitamin D can impact overall health, particularly in relation to bones and muscles.

According to FDA records, the recall involves 422 cases of the 0.25 mg product and 210 cases of the 1.0 mg product, with each case containing 12 bottles. The specific lot information for the recalled products includes:

– Lot 1692303, Serial Number 138909557498, Expiration Date: October 26, 2025
– Lot 1692304, Serial Number 131163901709, Expiration Date: October 26, 2025
– Lot 1712301, Serial Number 163590222021, Expiration Date: November 14, 2025

The recall is officially recorded under recall number H-0569-2026 and is linked to FDA Event ID 97884. Initial notifications regarding the recall were sent out via letter, and distribution records indicate the product reached multiple states and territories, including Alabama, Arizona, California, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Washington, Wisconsin, and West Virginia.

The recall was initiated on October 27, 2025, and the FDA assigned its risk classification on March 13, 2026. Currently, the recall is ongoing, with no specified termination date.

Understanding the Recall Classification

The FDA has classified this recall as Class III, which is the lowest risk category. A Class III recall indicates that exposure to the product is not likely to cause adverse health consequences, although the product does violate FDA regulations. This classification reflects the FDA’s assessment that the subpotency issue does not pose a significant health risk, while corrective action remains necessary.

Consumers who have purchased the affected multivitamins are encouraged to check their products against the recall details and consult with healthcare professionals if they have any concerns about their health.