ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg recall (Prodose, Inc.)
DrugClass IIIOngoing
Summary: Prodose, Inc. is recalling 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.
What is being recalled
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
Why
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
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot #: P260252, Exp 4/30/2029
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0081-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | October 14, 2026 |
| Reported | November 4, 2026 |
| Company | Prodose, Inc. |
| Company location | Ronkonkoma, NY, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 100,134 40-count bottles |
More recalls from Prodose, Inc. · all drug recalls · recalls from October 2026