FDA Initiates Recall of Multivitamins in 25 States Due to Low Vitamin D Levels

A nationwide recall has been issued for a chewable multivitamin product distributed across 25 states after federal inspectors discovered it contained lower-than-intended levels of vitamin D. The affected product is the Multivitamin with Fluoride Chewable Tablets, grape flavor, manufactured by Winder Laboratories, LLC based in Winder, Georgia.

This recall affects two specific versions of the multivitamin. The first version contains 0.25 mg of fluoride and is packaged in bottles of 100 tablets with the National Drug Code (NDC) 75826-169-10 and UPC 3 15826 16910 2. The second version contains 1.0 mg of fluoride, also in 100-tablet bottles, with NDC 75826-171-10 and UPC 3 15826 17110 5.

The recall was prompted by a U.S. Food and Drug Administration (FDA) inspection that found the vitamin D levels in these products were subpotent, meaning they were less than the intended amount. Vitamin D is crucial for bone health as it aids in calcium absorption and supports the immune system. Insufficient levels of this vitamin can lead to various health issues, particularly concerning bone and muscle health.

Details of the Recall

The voluntary recall, initiated on October 27, 2025, affects a total of 422 cases of the 0.25 mg fluoride product and 210 cases of the 1.0 mg fluoride product. Each case consists of 12 bottles of 100 tablets. Consumers can identify the affected products by the following lot numbers and expiration dates:

– 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 listed under recall number H-0569-2026 and is associated with FDA Event ID 97884. Initial notifications regarding the recall were sent out by letter.

Distribution records indicate that the product was shipped to various states and territories, including Alabama, California, Florida, and many others, highlighting the extensive reach of the recall.

FDA Classification and Health Impact

The FDA has classified this recall as a Class III recall, the agency’s lowest risk category. This classification is applied when exposure to a product is not likely to result in adverse health consequences, although it still violates FDA regulations. In this instance, the FDA assessed that the low vitamin D levels did not pose a significant health risk, while still necessitating corrective action from the manufacturer.

As the recall continues, the FDA has yet to announce a termination date. Consumers are advised to check their medicine cabinets for the affected products and follow any guidance provided in the notification letters. For further information, individuals can contact Winder Laboratories directly.