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Over 100,000 Bottles of Acetaminophen Recalled Due to Labeling Mistake

Over 100,000 Bottles of Acetaminophen Recalled Due to Labeling Mistake

Charna FlamWed, November 4, 2026 at 5:15 AM UTC

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ValuHealth AcetaminophenCredit: ValuHealth -

Prodose, Inc. voluntarily recalled its ValuHealth Extra Strength Pain Relief Acetaminophen on Oct. 14

The recall was due to a labeling mistake, with the bottle’s inner label incorrectly identifying the medication as a PM formula

The affected ValuHealth product is typically sold at Dollar Tree

The Food and Drug Administration (FDA) announced a recall of 100,134 bottles of ValuHealth Extra Strength Pain Relief Acetaminophen.

On Oct. 14, the federal agency issued the nationwide recall, citing a labeling mistake. An incorrect label was placed on the product: the outer label correctly identified it as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, but the bottle’s inner label identified it as ValuHealth Extra Strength Pain Relief PM.

ValuHealth is typically found at Dollar Tree. ValuHealth’s parent company, Prodose, Inc., voluntarily initiated the recall.

On Oct. 26, the FDA deemed the recall Class III, the least severe recall. The FDA states the “use of or exposure to a violative [Class III] product is not likely to cause adverse health consequences.”

The impacted product’s lot number is P260252, the Universal Product Code (UPC) is 850026889000 and the expiration date was April 30, 2029.

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PEOPLE reached out to ValuHealth for additional information.

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Prodose, Inc.’s voluntary recall of Acetaminophen comes nearly two months after over 100,000 bottles of Amazon-branded acetaminophen were recalled, per a previous FDA enforcement report.

On Sept. 18, Aurobindo Pharma USA Inc. recalled Amazon Basic Care Extra Strength Pain Relief due to “reports of tablet discoloration in the affected lots,” an Amazon spokesperson previously told PEOPLE. The discoloration does not affect the medication’s safety or efficacy, per a Health Hazard Evaluation. No adverse events have been reported.

The recall included extra-strength 500 mg acetaminophen that was sold in 200-count, 500-count and 1,000-count bottles, with 14,640; 90,456; and 7,836 bottles recalled, respectively.

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