FDAClass IIJune 19, 2024

Phenazopyridine HCl Tablets USP 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,

Why was Phenazopyridine HCl Tablets USP recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 1142404 Exp. Date 02/27/2027

Product
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,
Recalling firm
Winder Laboratories, LLC
Quantity
473 cases (5676 Bottles)
Distribution
Nationwide within the United States
Recall date
June 19, 2024
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls