Phenazopyridine Hydrochloride Tablet
FDA Recall NDC 75826-114
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Phenazopyridine Hydrochloride (NDC 75826-114). A significant event, classified as Class II, was initiated on May 28, 2024 by Winder Laboratories, Llc. The reported reason for this action was: "Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
May 2024 Class II Recall: Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Recall Number
Class II Completed
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
May 28, 2024
Jun 19, 2024
473 cases (5676 Bottles)
Recall Profile & Regulatory Data
Event ID
94727
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Winder Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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,
Batch or Lot Expiration Information
Lot# : 1142404 Exp. Date 02/27/2027
Affected Packages Involved in this Recall
75826-114-10Product
75826-115-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
