Prodose, Inc. Recalls ValuHealth Acetaminophen Due to Labeling Mistake

Prodose, Inc. has initiated a voluntary recall of its ValuHealth Extra Strength Pain Relief Acetaminophen due to a labeling error. This recall was announced on October 14, and it involves 100,134 bottles of the medication.

The labeling mistake involves the inner label of the bottles, which mistakenly identifies the medication as ValuHealth Extra Strength Pain Relief PM. However, the outer label correctly states it is ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg. This product is commonly sold at Dollar Tree stores. The U.S. Food and Drug Administration (FDA) classified this recall as Class III, indicating that it is the least severe, with no likely adverse health consequences from the use of the product.

The affected ValuHealth products have a lot number of P260252, a Universal Product Code (UPC) of 850026889000, and an expiration date of April 30, 2029.

This recall comes shortly after another acetaminophen recall 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. Despite the discoloration, the safety and efficacy of the medication remain unaffected, according to the Health Hazard Evaluation. The Amazon-related recall affected bottles of various counts including 200-count, 500-count, and 1,000-count bottles.

ValuHealth’s parent company, Prodose, Inc., took action to ensure the correct labeling of its products. The FDA’s classification of the recall aims to reassure consumers of the low risk involved.