FDA Announces Recall of ValuHealth Acetaminophen Due to Labeling Error

Background of the Recall

On October 14, Prodose, Inc. voluntarily recalled its ValuHealth Extra Strength Pain Relief Acetaminophen due to a labeling mistake. The recall affected 100,134 bottles, as announced by the Food and Drug Administration (FDA). The error involved the product’s inner label incorrectly identifying it as a PM formula, while the outer label correctly displayed it as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg.

Distribution and Action Taken

The affected medication is commonly available in Dollar Tree stores. In response to the labeling issue, Prodose, Inc. initiated the recall voluntarily. By October 26, the FDA classified the recall as a Class III. According to the FDA, exposure to Class III products is unlikely to cause adverse health consequences.

The recalled bottles have a lot number of P260252, a Universal Product Code (UPC) of 850026889000, and an expiration date set for April 30, 2029.

Previous Related Recalls

This recall follows a similar incident involving over 100,000 bottles of Amazon-branded acetaminophen. On September 18, Aurobindo Pharma USA Inc. recalled Amazon Basic Care Extra Strength Pain Relief due to reports of tablet discoloration in affected lots. Despite the discoloration, the Health Hazard Evaluation reported no impact on safety or efficacy, and no adverse events had been reported.

The Amazon recall covered bottles of extra-strength 500 mg acetaminophen sold in quantities of 200, 500, and 1,000 tablets, resulting in recalls of 14,640; 90,456; and 7,836 bottles, respectively.