Prodose, Inc. has recalled its ValuHealth Extra Strength Pain Relief Acetaminophen due to a labeling mistake. The recall, issued on October 14, affects 100,134 bottles of the medication. The error lies in the inner label incorrectly identifying the product as a PM formula instead of its actual formulation.
The Food and Drug Administration (FDA) categorized the recall as Class III, indicating that the product’s use or exposure is unlikely to cause adverse health consequences. The recalled product lot number is P260252, with a Universal Product Code (UPC) of 850026889000 and an expiration date set for April 30, 2029.
ValuHealth products are commonly sold at Dollar Tree locations. Prodose, Inc. voluntarily initiated the recall as soon as the labeling error was discovered. The FDA has provided reassurance regarding the recall’s severity, stating that it is not expected to lead to adverse effects on health.
This recall follows a previous FDA enforcement action against Aurobindo Pharma USA Inc. On September 18, over 100,000 bottles of Amazon Basic Care Extra Strength Pain Relief were recalled due to tablet discoloration within certain lots. Despite the discoloration, the medication’s safety and efficacy remained intact. No adverse incidents were reported.
The affected Amazon-branded acetaminophen included 500 mg tablets sold in bottle sizes of 200-count, 500-count, and 1,000-count. The recall encompassed 14,640; 90,456; and 7,836 bottles, respectively.
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