Reported Jun 19, 2024 · Completed

Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716…

Winder Laboratories, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Winder Laboratories, LLC · 716 Patrick Industrial Ln · Winder, GA · 30680-8333

Is this the product you have?

  • 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
Lot codes and dates
  • Lot#: 1142404 Exp. Date 02/27/2027
Amount recalled
473 cases (5676 Bottles)

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 4:18 PM UTC

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