ValuHealth Recalls Over 100,000 Acetaminophen Bottles

The recall follows a labeling error that incorrectly identified the pain medication as a sleep aid.

Updated on Oct. 27, 2026 in Allergies

Isometric editorial illustration of two generic medicine bottles on a sterile surface, representing a product labeling recall. — ValuHealth has issued a Class III recall for over 100,000 bottles of acetaminophen due to an inner-labeling error. AI Illustration. Upload story photo >

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ValuHealth has recalled 100,134 bottles of its Extra Strength Pain Relief Acetaminophen after discovering an inner label error. While the outer carton is labeled correctly, the inner bottle incorrectly identifies the product as Extra Strength Pain Relief PM.

Why it matters

The recall was initiated because the mislabeled bottles could lead consumers to believe they are taking a sleep aid containing diphenhydramine when they are actually consuming 500 mg of acetaminophen. This poses a potential risk for those with specific allergies or sensitivities to ingredients not listed on the intended product label.

The recall involves 100,134 bottles of 500 mg acetaminophen, with the mislabeled bottles incorrectly stating the product contains 25 mg of diphenhydramine. These products are marked with lot number P260252 and an expiration date of April 30, 2029.

The players

ValuHealth

ValuHealth is a pharmaceutical manufacturer responsible for producing and distributing the recalled acetaminophen products across the United States.

FDA

The Food and Drug Administration is the federal agency responsible for overseeing product safety and classifying the recall status of consumer medications.

The details

The FDA classified this action as a Class III recall, meaning the medication is not likely to cause adverse health consequences. Consumers should verify the inner bottle labels against the product carton to ensure they are using the correct medication.

October 14, 2026: The manufacturer initiated the product recall.
October 26, 2026: The FDA officially classified the recall as Class III.
April 30, 2029: This is the expiration date printed on the recalled lot.

Health Landscape

This action follows the FDA's Class III recall classification system, which establishes clear protocols for addressing labeling inconsistencies in consumer healthcare. The classification confirms that the agency views the mislabeling as a technical compliance issue rather than a public health threat.

Patients who have purchased ValuHealth 40-count bottles should inspect their inner labels for the incorrect 'PM' designation to avoid confusion. If you find a mislabeled bottle, discontinue use of the product and contact the manufacturer for further guidance on safety.

The takeaway

Always verify that the medication inside the bottle matches the description on the outer carton before starting any new dose. If you have concerns about mislabeled pharmaceutical products, report them to the manufacturer or the FDA to ensure community safety.