Walgreens Facing Class Action Over Allegedly Illegal Sale of Urinary Pain Relief Tablets

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Walgreens faces a proposed class action over its allegedly illegal sale of certain over-the-counter (OTC) Urinary Pain Relief tablets.

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The 21-page lawsuit says that unbeknownst to consumers, the Walgreens-brand products at issue are illegal to sell because their active ingredient—phenazopyridine hydrochloride—has never gone through the required OTC drug review processes.

Before an OTC drug can be legally placed on the market, it must undergo one of two processes overseen by the U.S. Food and Drug Administration (FDA) to ensure it’s safe and effective for its intended use, the case explains. Under the first pathway, manufacturers can get approval from the FDA to sell an OTC drug in the form of a finished product by submitting a drug application, which includes clinical trial data demonstrating its safety and effectiveness, the filing relays.

Alternatively, a manufacturer can bring an OTC drug into the market by using the OTC drug monograph process to test its active ingredient, the suit explains. The complaint says that an OTC monograph is essentially a “rule book” that defines “specific conditions” under which an OTC drug is “generally recognized as safe and effective” (GRASE) for its intended use.

“Compliance with the regulations and requirements outlined in established OTC drug monographs is assessed by the FDA during the inspection process to ensure GRASE standards are met before a finished drug product can be marketed,” the case says.

The complaint stresses that phenazopyridine hydrochloride, as of the suit’s filing on January 17, 2024, has neither received FDA approval nor been brought to market under an established OTC drug monograph.

As such, “[Walgreens] sells [phenazopyridine hydrochloride] to treat [urinary tract infections] even though it is unsafe, ineffective, and unlawful to sell,” the filing argues. According to the case, the pharmacy’s “unfair, deceptive, untrue, and misleading” business practices have tricked consumers into believing they were purchasing a finished product that has been approved for lawful sale.

The lawsuit looks to represent anyone in the United States who purchased the Urinary Pain Relief products with phenazopyridine hydrochloride from Walgreens within the past four years.

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