Class II

Drug Recall: 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,

Winder Laboratories, LLC · May 28, 2024

Reason for Recall

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

Distribution

Nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

473 cases (5676 Bottles)

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0545-2024

Status: completed

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.