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Drug FDA Class II Completed Mislabeling

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 Published Jun 19, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Winder Laboratories, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Phenobarbital tablets 16.2 mg substituted for Phenazopyridine HCl · primary

Affected products (1)

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,

PHENAZOPYRIDINE HYDROCHLORIDE · 473 cases (5676 Bottles)

NDC: 75826-114, 75826-115, 75826-114-10, 75826-115-10
Code info: Lot#: 1142404 Exp. Date 02/27/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    May 28, 2024
  2. Published
    Jun 19, 2024
Recall number
D-0545-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.