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Winder Laboratories, LLC Recall: Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.

United States

OngoingClass III

Company
Winder Laboratories, LLC
Product
Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx…
Recall date
October 27, 2025
Source
FDA

Reason for recall

Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.

  1. - Recall initiated
  2. - Reported by source
Recalled products
Product description UPC Quantity Lot / code information
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 Not published in this source record 422cs/12/0.25mg/100ct bottles + 210cs/12/1.0mg/100ct bottles Lot 1692303 SN: 138909557498 EXP: 2025-10-26 & Lot 1692304 SN 131163901709 EXP: 2025-10-26; LOT 1712301 SN: 163590222021 EXP: 2025-11-14

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.

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
H-0569-2026
Event ID
97884
Status
Ongoing
Classification
Class III
Company
Winder Laboratories, LLC
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
Quantity
422cs/12/0.25mg/100ct bottles + 210cs/12/1.0mg/100ct bottles
Reason
Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
Recall initiation date
October 27, 2025
Report date
March 25, 2026
Classification date
Not published in this source record
Termination date
Not terminated as of this source record
Distribution pattern
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.
UPC, lot, and code information
Lot 1692303 SN: 138909557498 EXP: 2025-10-26 & Lot 1692304 SN 131163901709 EXP: 2025-10-26; LOT 1712301 SN: 163590222021 EXP: 2025-11-14
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Letter
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Responsible company: Winder Laboratories, LLC

Other recalls from Winder Laboratories, LLC

FDA Recall Ongoing Historical recordClass III

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01

by Winder Laboratories, LLC

Published
December 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Completed Historical recordClass II

Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,

by Winder Laboratories, LLC

Published
June 19, 2024
Distribution
Nationwide

View recall →

Distribution map

A map highlighting the states named in the source's distribution description.

Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.

Distribution map
State Distributed
Alabama 1
Arizona 1
California 1
Florida 1
Hawaii 1
Iowa 1
Illinois 1
Indiana 1
Massachusetts 1
Michigan 1
Missouri 1
Mississippi 1
North Carolina 1
New Jersey 1
New York 1
Oregon 1
Pennsylvania 1
Puerto Rico 1
Rhode Island 1
Tennessee 1
Texas 1
Utah 1
Washington 1
Wisconsin 1
West Virginia 1

States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class III mean?

A situation in which use of or exposure to a product is not likely to cause adverse health consequences.

Is this recall still active?

According to FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.