Multivitamin with Fluoride Chewable Tablets Recalled for Subpotent Vitamin D
Winder Laboratories is recalling Multivitamin with Fluoride Chewable Tablets Grape Flavor because the product contains subpotent Vitamin D levels. The FDA discovered this deficiency during an inspection.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recalls are by definition unlikely to cause adverse health consequences. The hazard is a labeling/potency deficiency with no reported illnesses or injuries, and the substance involved (Vitamin D) does not present acute toxicity risk at subpotent levels.
Plain-English summary
Winder Laboratories, LLC is recalling Multivitamin with Fluoride Chewable Tablets Grape Flavor, manufactured in Winder, Georgia. The product is available in two strengths: NDC 75826-169-10 (0.25 mg, 100 tablets per bottle) and NDC 75826-171-10 (1 mg, 100 tablets per bottle).
During an FDA inspection, it was discovered that the product was subpotent for Vitamin D. This means the tablets contain lower levels of Vitamin D than indicated on the label.
The recalled product was distributed to the following states: 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. Affected lot numbers include Lot 1692303 and 1692304 (expiration 2025-10-26) and Lot 1712301 (expiration 2025-11-14).
Consumers who have purchased this product should stop using it and consult with their healthcare provider about appropriate vitamin supplementation. Affected bottles may be returned to the place of purchase for a refund.
The recalled product
- Product
- Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDC 75826-171-10 1mg 100 TABLETS UPC 3 15826 17110 5 Manufactured by: WINDER LABORATORIES LLC Winder, GA 30680
- Manufacturer
- Winder Laboratories, LLC
- Category
- Drug — Vitamin Supplement
- Hazard
- subpotency
- vitamin-d
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 1712301 SN: 163590222021 EXP: 2025-11-14
Distribution
Distributed in 25 states:
- AL
- AZ
- CA
- FL
- HI
- IA
- IL
- IN
- MA
- MI
- MO
- MS
- NC
- NJ
- NY
- OR
- PA
- PR
- RI
- TN
- TX
- UT
- WA
- WI
- WV
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