Prodose, Inc.: Valuhealth Extra Strength Pain Relief Acetaminophen 500 Mg, 40-caplets Per Bottle

Recall Summary ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg bottles (40-caplets) distributed by Prodose, Inc. are being recalled because the label on the bottle incorrectly says "Pain Relief PM" instead of the correct product name, even though the outer carton is labeled correctly. The product was distributed nationwide across all U.S. states and territories. This labeling error could cause consumers to take the wrong medication or become confused about what they're taking.

Recalling firm
Prodose, Inc.
Product
ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, Distributed by:Prodose, Inc. Ronkonkoma, NY 11779, Made in India. UPC 8 50026 88900 0
Reason
Incorrect label placed on product: Outer carton label correctly identifies drug product in bottle as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg,but inner label on bottle says ValuHealth Extra Strength Pain Relief PM
Classification
Class III
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-10-14
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/de47a23e-ff99-4e1b-9f50-bdfe5ff0b438