A chewable multivitamin distributed across 25 states has been recalled after the U.S. Food and Drug Administration (FDA) found that it contained lower-than-intended levels of vitamin D. The recall involves the product known as Multivitamin with Fluoride Chewable Tablets, specifically the grape flavor, which is manufactured by Winder Laboratories, LLC, based in Winder, Georgia.
The issue was identified during a routine inspection by federal authorities, prompting a voluntary recall by the manufacturer. The affected products include two formulations of the multivitamin. One version contains 0.25 mg of fluoride in bottles of 100 tablets, carrying the National Drug Code (NDC) 75826-169-10 and Universal Product Code (UPC) 3 15826 16910 2. The second version includes 1.0 mg of fluoride, also in bottles of 100 tablets, with NDC 75826-171-10 and UPC 3 15826 17110 5.
Vitamin D is essential for bone health as it aids in calcium absorption and supports the immune system. Insufficient levels can lead to health issues, particularly concerning bone and muscle strength. As a result of the FDA’s findings, the recall affects 422 cases of the 0.25 mg product and 210 cases of the 1.0 mg product. Each case contains 12 bottles of 100 tablets.
Details of the Recall
Consumers can identify the impacted products by their lot information. The relevant lots include:
– 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, designated as H-0569-2026, falls under FDA Event ID 97884. Initial notifications regarding the recall were sent out via letter to distributors. The products were shipped to various states, including Alabama, Arizona, California, Florida, Hawaii, and others.
The recall was initiated on October 27, 2025, with the FDA assigning its risk classification on March 13, 2026. This ongoing recall currently has no specified termination date.
Understanding the Recall Classification
The FDA classified this multivitamin recall as Class III, the agency’s lowest risk category. A Class III recall is issued when the use or exposure to a product is unlikely to cause adverse health consequences, yet the product still violates FDA regulations. In this case, the FDA’s classification indicates that while the subpotency issue does not pose a significant health risk, corrective action is still necessary.
Consumers are urged to check their cabinets for the affected products and to contact their healthcare providers if they have concerns about their health. For further information, individuals can refer to the FDA’s website or contact Winder Laboratories directly.
