Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Phenazopyridine Hydrochloride Tablets Recalled by Nationwide Laboratories, LLC Due to CGMP Deviations: manufactured under practices which may result...

Date: October 28, 2016
Company: Nationwide Laboratories, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nationwide Laboratories, LLC directly.

Affected Products

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.

Quantity: 6,333,669 tablets

Why Was This Recalled?

CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nationwide Laboratories, LLC

Nationwide Laboratories, LLC has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report