A drug manufacturer is recalling more than 100,000 bottles of acetaminophen sold by ValuHealth due to incorrect labeling, according to a notice published this week by the Food and Drug Administration (FDA).

ValuHealth Extra Strength Pain Relief Acetaminophen in 500-milligram caplets is being recalled, according to the notice. The medication was distributed by New York-based Prodose, Inc., and manufactured in India.

Overall, 100,134 40-count bottles are under recall, the notice said, adding that the over-the-counter medication was distributed throughout the United States.

The lot under recall is P260252, while the medication’s expiration is April 30, 2029, the notice said.

The reason for the recall is due to an “incorrect label” being “placed on product.”

“Outer carton label correctly identifies drug product in bottle as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg,” the enforcement report stated. However, the “inner label on bottle says ValuHealth Extra Strength Pain Relief PM,” it added.

ValuHealth Extra Strength Pain Relief PM contains 500 milligrams of acetaminophen and 25 milligrams of diphenhydramine, a sedative and antihistamine commonly sold under the brand name Benadryl, according to a Dollar Tree listing. ValuHealth is an over-the-counter medication brand that is sold primarily at Dollar Tree locations.

The recall was initiated on Oct. 14, while the FDA classified the action as Class III, or the least severe on a three-tiered list, on Oct. 26. A Class III recall is described by the FDA as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

“Using the drug is not likely to cause health consequences” under a Class III recall, the FDA says.

The FDA or the recalling company did not provide any guidance on what consumers should do if they have the recalled item.

“For example, a class III recall could include certain concerns about minor drug labeling errors, defective packaging or incorrect expiration dates,” the agency says. “These recalls are generally conducted at the wholesale level, and patients and consumers can continue using the medicine unless otherwise directed by the recalling company or FDA.”

Earlier this month, an FDA notice said that 113,000 bottles of generic acetaminophen sold through Amazon were recalled due to discoloration complaints. The recall impacted caplets in 500-milligram strength, in 200-count, 500-count, and 1,000-count bottles.

Acetaminophen, which is commonly sold under the brand name Tylenol, is among the most common pain relievers in U.S. homes and is also called paracetamol in Europe, the UK, and other countries. Tylenol products were not impacted by the recent recalls.