FDA-Drug2026-10-26Class IIIMISBRANDING
ValuHealth Extra Strength Pain Relief Acetaminophen recalled for incorrect bottle labeling
What this means
ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg bottles have an incorrect label on the bottle itself. The outer carton correctly says "Acetaminophen 500 mg," but the label on the bottle says "Pain Relief PM" — a different product. This mismatch could cause confusion about what you're taking.
- Check if you have ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplet bottles with Lot # P260252 (expiration 4/30/2029).
- Compare the label on the bottle to the label on the outer carton.
- If the bottle says "Pain Relief PM" but the box says "Acetaminophen 500 mg," do not use it.
- Contact the pharmacy or retailer where you purchased it for a replacement or refund.
The agency's original wording
Hazard
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
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
100,134 40-count bottles
Manufactured in
2004 Orville Dr N Ste 2, Ronkonkoma, New York, United States
Products
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
UPC codes
- 850026889000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0081-2027Want us to check the next one for you?
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