More Than 100,000 Bottles of ValuHealth Acetaminophen Recalled Over Labeling Error

More than 100,000 bottles of over-the-counter pain relief medication sold under the ValuHealth brand are being recalled across the United States because of an incorrect product label, according to a notice published by the U.S. Food and Drug Administration (FDA).

The recall affects ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg caplets. Although the outer packaging identifies the product correctly, the label attached to the individual bottle describes a different medication. This discrepancy could create confusion for consumers purchasing or using the product.

The recall involves 100,134 bottles distributed nationwide. Consumers who regularly purchase over-the-counter pain relievers should check the product information carefully to determine whether their medication is included in the recall.

What Is Behind the ValuHealth Acetaminophen Recall?

According to the FDA enforcement notice, the recall was initiated because an incorrect label was placed on the product.

The outer carton correctly identifies the medication as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg. However, the label on the bottle identifies the contents as ValuHealth Extra Strength Pain Relief PM.

These two products have different formulations. Standard extra-strength acetaminophen contains an active ingredient commonly used to relieve pain and reduce fever. The nighttime version contains additional medication intended to help with nighttime symptoms.

The labeling discrepancy is important because consumers rely on the information printed directly on medicine bottles to identify ingredients, understand a product's intended use, and determine whether it is appropriate for them.

Even when a recall is classified as low risk, incorrect medication labeling deserves attention because it can lead to uncertainty about the ingredients in a product.

Which Products Are Included in the Recall?

Consumers can use the following information to identify the affected medication.

• Brand: ValuHealth
• Product name on the outer carton: Extra Strength Pain Relief Acetaminophen
• Strength: 500 mg caplets
• Bottle size: 40-count
• Quantity recalled: 100,134 bottles
• Affected lot number: P260252
• Expiration date: April 30, 2029
• Distributor: Prodose, Inc., based in New York
• Country of manufacture: India
• Distribution area: United States

The affected medication was distributed nationwide, according to the FDA notice.

Consumers should compare the lot number and expiration date on their packaging with the information above. Checking the product name alone may not be sufficient because the recall specifically involves a discrepancy between the outer carton and the label on the bottle.

The FDA enforcement report provides additional information about the recalled product.

Why Is the Incorrect Label a Concern?

The main concern is that the bottle label identifies the product as a nighttime pain relief medication rather than standard extra-strength acetaminophen.

ValuHealth Extra Strength Pain Relief PM contains 500 mg of acetaminophen and 25 mg of diphenhydramine, an antihistamine that can cause drowsiness. Diphenhydramine is also an ingredient found in certain products sold under the Benadryl brand.

Because the two formulations differ, the labeling error could make it more difficult for consumers to determine exactly which medication they have purchased.

Acetaminophen is commonly used to relieve mild to moderate pain and reduce fever. Diphenhydramine, meanwhile, is used for purposes that include allergy symptom relief and, in some nighttime products, assistance with occasional sleeplessness.

The presence of an additional active ingredient can affect how a medication should be used and which precautions apply.

Consumers should never assume that two products are interchangeable simply because they share a similar name or contain the same amount of acetaminophen.

FDA Classifies the Recall as Class III

The FDA initiated the recall on October 14, 2026, and classified it as a Class III recall on October 26, 2026.

The agency uses three recall classifications to describe the potential health risks associated with recalled products.

A Class I recall represents the most serious category, involving a reasonable probability that a product could cause serious adverse health consequences or death.

A Class II recall applies when exposure may cause temporary or medically reversible health consequences, or when the probability of serious adverse consequences is remote.

A Class III recall is the least severe category. It applies when using or being exposed to a product is not likely to cause adverse health consequences.

The ValuHealth recall falls into this third category because the FDA determined that the violation was unlikely to result in adverse health consequences.

However, a Class III classification does not mean that consumers should ignore a product recall. The classification reflects the agency's assessment of the risk associated with the violation, rather than a guarantee that every possible use of the product is safe.

Consumers should review the official recall notice and follow any additional instructions issued by the manufacturer, distributor, or FDA.

What Should Consumers Do If They Have the Recalled Medication?

The FDA notice provided no specific consumer instructions for people who may have purchased the affected bottles.

As a precaution, consumers should verify the lot number, expiration date, and product labeling before making decisions about the medication.

Anyone who identifies a potentially affected bottle can consult the official FDA enforcement report or contact the product distributor for clarification about the recall and any recommended next steps.

Consumers who are uncertain about which formulation they have should avoid relying solely on the outer carton or bottle name to identify the ingredients. A pharmacist or healthcare professional can help explain the differences between standard acetaminophen and nighttime formulations.

People who have already taken the medication and are concerned about possible exposure should seek advice from a qualified healthcare professional. Anyone experiencing a serious or unexpected reaction should seek appropriate medical attention.

It is also important to follow the dosing instructions for acetaminophen products. Taking more than the recommended amount can cause serious liver damage, particularly when multiple medications containing acetaminophen are used together.

Another Acetaminophen Recall Reported Earlier This Month

The ValuHealth recall follows another reported recall involving generic acetaminophen sold through Amazon.

An earlier FDA notice described a recall affecting approximately 113,000 bottles of 500 mg acetaminophen caplets after complaints about discoloration.

That action involved bottles containing 200, 500, and 1,000 caplets.

Although both recalls involve acetaminophen products, the reported reasons differ. The ValuHealth recall concerns incorrect labeling, while the earlier action involved complaints about the appearance of the medication.

Consumers should not assume that all acetaminophen products are affected by these recalls.

The ValuHealth action applies to the specific product, lot number, and packaging details identified in the FDA notice. The earlier recall concerns a separate product.

The reports also do not indicate that all products containing acetaminophen, including Tylenol, are subject to the ValuHealth recall.

Why Medication Label Accuracy Matters

Accurate labeling is essential for the safe use of over-the-counter medications. Product labels help consumers identify active ingredients, understand intended uses, review dosage instructions, and recognize important warnings.

When a bottle label conflicts with the information on its outer packaging, consumers may have difficulty determining which formulation they possess.

This can be particularly important for products that contain multiple active ingredients, including nighttime medications that may cause drowsiness.

Consumers can reduce the risk of medication errors by reading labels carefully, checking active ingredients, following dosage instructions, and consulting pharmacists when information appears inconsistent.

Manufacturers and distributors also have an important role in ensuring that products are packaged and labeled correctly before they reach store shelves.

The ValuHealth recall highlights why consumers should pay attention to official safety notices, even when a recall is classified as low risk.

Final Thoughts

The recall of 100,134 bottles of ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg highlights a labeling discrepancy involving standard acetaminophen and a nighttime pain relief formulation.

The affected bottles carry lot number P260252 and an expiration date of April 30, 2029. The FDA classified the action as Class III, indicating that adverse health consequences are not likely.

Consumers who have purchased the product should check the identifying details carefully and consult the FDA notice or a pharmacist if they have questions about the medication.

Staying informed about recalls and understanding the ingredients in over-the-counter products can help consumers make more informed decisions about medication use.

Disclaimer

This article is intended for informational and educational purposes only and should not be considered medical advice. Information is based on the FDA recall notice and the source material available at the time of writing. Recall information and official recommendations may change. Consumers should consult the FDA, the product distributor, a pharmacist, or a qualified healthcare professional for current guidance regarding affected products. Do not change or discontinue prescribed treatment without consulting your healthcare provider.