ValuHealth Extra Strength Acetaminophen Recalled Due to Incorrect Labeling

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class III recall for ValuHealth extra strength pain relief acetaminophen, 500 mg. The affected batch has been identified as Lot P260252 (expiring April 2029), containing 100 134 bottles.
• The recall was initiated by Prodose, Inc due to incorrect labeling of product, a quality issue that is not likely to cause adverse health consequences.
• Acetaminophen is used to relieve pain and reduce fevers.

The FDA has issued a Class III recall for ValuHealth extra strength pain relief acetaminophen, 500 mg, affecting 100 134 bottles. This product is being recalled by Prodose, Inc based in Ronkonkoma, New York. The recall was initiated on October 14, 2026, and received a Class III classification on October 26, 2026. A Class III classification means the use of this product is not likely to cause adverse health consequences.

The recall was initiated after the firm realized the product was incorrectly labeled as ValuHealth Extra Strength Pain Relief PM. This issue affects Lot P260252, which will expire in April 2029. Prodose has sent out a public notice via letter; no press release has been issued for this recall.

Acetaminophen is used to relieve minor pain and reduce fevers. Pharmacists should identify and quarantine Lot P260252, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. November 4, 2026. Accessed November 4, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=223387