Winder, GA, United States
Winder Laboratories, LLC recalls
3 recalls recorded since 2018, most recently on 26 November 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 26 November 2025
- Reason
- Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0223-2026
- 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
Ongoing Class III Food
- Recall started
- 27 October 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- H-0569-2026
- 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,
Completed Class II Drugs
- Recall started
- 28 May 2024
- Reason
- Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0545-2024
- 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,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.