Winder Laboratories, LLC: Drug Recall

Recall #D-0545-2024 · 05/28/2024

Class II: Risk

Recall Details

Recall Number: D-0545-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Winder Laboratories, LLC
Status: Completed
Date Initiated: 05/28/2024
Location: Winder, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 473 cases (5676 Bottles)

Reason for Recall

Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Product Description

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,

Distribution Pattern

Nationwide within the United States

Other Recalls by Winder Laboratories, LLC

Class III: Low Risk 11/26/2025

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

View all recalls by Winder Laboratories, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.