Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; ND
Summary
The FDA issued a Class III for Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.2 by Winder Laboratories, LLC. Reason: Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D..
Details
Source
Food Recall
External ID
H-0569-2026
Action Date
2026-03-25
Status
Ongoing
Category
food
Product Description
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
Lot/Code Info: Lot 1692303 SN: 138909557498 EXP: 2025-10-26 & Lot 1692304 SN 131163901709 EXP: 2025-10-26; LOT 1712301 SN: 163590222021 EXP: 2025-11-14
Quantity Affected: 422cs/12/0.25mg/100ct bottles + 210cs/12/1.0mg/100ct bottles
Reason for Recall
Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
Distribution
Product was shipped to the following 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-27
Company
Winder, GA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 48 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Winder Laboratories, LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Winder Laboratories, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Winder Laboratories, LLC have FDA actions?
Winder Laboratories, LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0569-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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