Reported Nov 4, 2026 · Ongoing

ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, Distributed by:Prodose, Inc.…

Prodose, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Prodose, Inc. · 2004 Orville Dr N Ste 2 · Ronkonkoma, NY · 11779-7645

Is this the product you have?

  • ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle
  • Distributed byProdose, Inc. Ronkonkoma, NY 11779, Made in India. UPC 8 50026 88900 0
Lot codes and dates
    • Lot #: P260252
    • Exp 4/30/2029
Amount recalled
100,134 40-count bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Nov 4, 12:19 AM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.