Use caution Drug recall · FDA · Published October 14, 2026

ValuHealth Acetaminophen Recall: Labeling Error

Prodose recalls ValuHealth Extra Strength Pain Relief Acetaminophen due to incorrect inner labeling that says 'PM'. Check your bottle.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0081-2027Drug ValuHealth ›

Use caution until it’s fixed

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

✎ GovInfoNow plain-language explainer

Prodose, Inc. is recalling ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg because the inner bottle label incorrectly identifies the product as 'ValuHealth Extra Strength Pain Relief PM.' This means consumers taking the medication for daytime pain relief may inadvertently ingest ingredients intended for nighttime use. The recall affects 100,134 bottles distributed nationwide. Read more at govinfonow.com/recall/2084716-prodose-inc-recalls-valuhealth-extra-strength-pain-relief-acetaminophen-500.

Source Summary by GovInfoNow · govinfonow.com/recall/2084716-prodose-inc-recalls-valuhealth-extra-strength-pain-relief-acetaminophen-500 · Published November 10, 2026 · Updated November 11, 2026 · FDA enforcement record: FDA #D-0081-2027

Cite this page

“ValuHealth Acetaminophen Recall: Labeling Error.” GovInfoNow, updated November 11, 2026. https://govinfonow.com/recall/2084716-prodose-inc-recalls-valuhealth-extra-strength-pain-relief-acetaminophen-500. Based on FDA recall #D-0081-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0081-2027%22&limit=1).

Prodose, Inc. recalled ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg due to incorrect labeling, according to the FDA on Oct. 14, 2026. The hazard involves inner labels stating 'PM' while outer cartons identify the product as non-PM acetaminophen.

How to tell if you have it

ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg
40-caplets per bottle
Distributed by: Prodose, Inc.
UPC 8 50026 88900 0
Lot #: P260252
Exp 4/30/2029

The hazard

The outer carton correctly identifies the drug as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, but the inner label on the bottle says ValuHealth Extra Strength Pain Relief PM. This labeling error was reported in a Class III recall.

Context

GovInfoNow's records show other recent recalls of similar products include Meitheal Recalls Vecuronium Bromide Due to Labeling Errors (2026-10-08), Glenmark Recalls Abiraterone Acetate Tablets Due to Labeling Issue (2026-10-09), and American Health Packaging Buprenorphine Tablets Recall: Label Mix-Up Hazard (2026-08-19).

How to tell if you have this one

Check your bottle for the following specific details: Brand 'ValuHealth', product name 'Extra Strength Pain Relief Acetaminophen 500 mg', 40 caplets per bottle. Look at the inner label on the bottle itself; if it says 'PM' instead of matching the outer carton, it is part of the recall. The affected lot number is P260252 with an expiration date of 4/30/2029 and UPC 8 50026 88900 0.

Brand
ValuHealth
Product
ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, Distributed by:Prodose, Inc
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Bottle Label
Verify if the inner label on your bottle says 'ValuHealth Extra Strength Pain Relief PM' while the outer box says 'Extra Strength Pain Relief Acetaminophen'.
Stop Using Affected Product
If your bottle matches the description above, do not consume the medication due to the potential for taking an unintended nighttime formulation.
Contact Manufacturer for Remedy
The recall record does not specify a remedy or return process; contact Prodose, Inc. in Ronkonkoma, NY for further instructions.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

Oct 14, 2026Firm started the recall
Oct 26, 2026FDA classified it Class III
Nov 4, 2026Published in FDA’s Enforcement Report
Nov 10, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/2084716-prodose-inc-recalls-valuhealth-extra-strength-pain-relief-acetaminophen-500">ValuHealth Acetaminophen Recall: Labeling Error (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0081-2027 (October 14, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0081-2027 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on November 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.