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Home › FDA recalls › ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg
CLASS III · LowFDA

Prodose, Inc. recalls ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg

📅 Oct 14, 2026 · 📍 Nationwide
Recalling company
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 – not likely to cause adverse health consequences
Recall date
Oct 14, 2026
Reported
Nov 4, 2026
Distribution
Nationwide in the USA
Status
Ongoing
Quantity
100,134 40-count bottles
Lot / codes
Lot #: P260252, Exp 4/30/2029
Company location
Ronkonkoma, NY
Recall type
Voluntary: Firm initiated
Recall number
D-0081-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0081-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.