FDA recall, , Low risk
ValuHealth Extra Strength Pain Relief Acetaminophen
ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg has an incorrect label on the bottle.
Summary by Recall Canary from the FDA notice
What happened
Prodose, Inc. of Ronkonkoma, New York, voluntarily recalled ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, because the inner label on the bottle incorrectly identifies the product as ValuHealth Extra Strength Pain Relief PM. The outer carton label correctly identifies the drug product as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg. The product was distributed nationwide in the USA and was made in India.
The recall began on October 14, 2026, and was added to the FDA's Enforcement Report on October 26, 2026. Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the UPC and lot code listed under your product.
A UPC is the number printed under a barcode.
ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg
- UPC
- 8 50026 88900 0
- Lot code
- P260252
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Nationwide in the USA
- Recalled by
- Prodose, Inc.Ronkonkoma, New York
- Hazard
- Labeling error
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- FDA event number
- 100132
- Recall number
- D-0081-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Prodose, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Prodose began the recall
FDA posted the recall to its Enforcement Report and rated it Class III (low risk)
Added to Recall Canary
Summary updated
