Are OTC Pain Relief Patches Safe to Use? What to Know About the Latest Recall

In November 2024, the FDA issued a drug recall affecting 15 million medicated pain patches. The recalled patches are used for pain relief and are sold over the counter (OTC). They contain ingredients such as lidocaine, camphor, and menthol — among others.

A drug recall is when a medication product is removed from the market. There can be several reasons for a drug recall, including contamination with potentially harmful chemicals, misleading information on the medication label, or a mechanical issue with the product. About 4,500 medications and medical devices are recalled each year.

Here, we’ll cover key considerations about the OTC pain relief patch recall, and what to do if your product is affected.

Why are some brands of pain patches being recalled?

A company called Unexo Life Sciences manufactures several medication patch products. One of Unexo’s drug manufacturing facilities in New Delhi, India was flagged by the FDA for not following Current Good Manufacturing Practice (cGMP) regulations.

Drug manufacturing facilities registered with the FDA are required to comply with cGMP regulations to ensure they’re creating products that are safe and high quality. If the FDA finds that a facility isn’t following these regulations, the agency may recommend that the company recall (remove) their medications from the U.S. market. This can be temporary or permanent.

The FDA listed several ways Unexo wasn’t following cGMP regulations, including issues with:

• Quality assurance over the final drug products

• Documentation for the products they produce

• Data showing that their products were tested appropriately prior to entering the market

• Control over computer systems, so that only specific personnel can access certain documents and records

• Cleanliness and sanitization of equipment

In short, the FDA doesn’t believe that the manufacturing facility in New Delhi is ensuring the safety or quality of the medication patches being sold in the U.S. For this reason, the FDA recommended that Unexo recall products produced at this facility, and Unexo complied.

Which pain patches have been recalled?

Eleven pain patch products were affected by the recall. These products were distributed throughout the U.S. The names of the patch products are below:

• Absorbine Jr. Extra Large Back Patch (menthol 5%)

• Absorbine Jr. Ultra Strength Pain Patch (menthol 6.5%)

• Absorbine Pain Relieving Knee Patch (camphor 7% / menthol 7%)

• Theracare Maximum Strength Pain Relief (lidocaine 4%)

• Theracare Cold Hot Medicated Patch (menthol 5%)

• HealthWise Period Patch Menstrual Pain Relief (menthol 10%)

• Equate Maximum Strength Lidocaine Pain Relieving Patch (lidocaine 4%)

• Lilas Feminine Pain Relief Patch (menthol 10%)

• JR Watkins Cooling Pain Relief Patches (menthol 7.5%)

• Cheeky Bonsai Pain Relief Patches (menthol 10%)

• Parche Leon Pain Relieving Hot Patch (camphor 3% / menthol 1.25% / capsaicin 0.025%)

EXPERT PICKS: WHAT TO READ NEXT

• Why drugs are recalled: Learn more about the top reasons why drugs are recalled, plus steps you should take if you’re affected by a recall.

• Recalls 101: If a medical product has an issue that can potentially cause harm to the public, it may be recalled. Read about how FDA recalls work.

• Lidocaine patches: Learn about these patches for pain relief and what products are available OTC versus prescription-only.

Keep in mind that this patch recall wasn’t announced in a formal FDA press release. Rather, the recall is detailed on the FDA website in an “enforcement report.” FDA Enforcement Reports contain information about drug recalls. Below, you can find the universal product code (UPC) and the number of patches recalled for each affected product.

What should you do if your patch product has been recalled?

If you have a patch that’s been recalled, don’t use it. Even if it’s worked for you in the past, it may not be safe.

If you think you’ve experienced side effects from one of these patches, or you notice quality concerns, you can report the issue to the FDA. It’s also a good idea to check in with a healthcare professional so they can assess whether you need any further assistance or treatment.

Keep in mind that other pain patches are available that haven’t been recalled. Some are available OTC. Examples include:

• Lidocaine 4% / menthol 1% patches (Icy Hot Max)

• Menthol 5% (Icy Hot Original)

• Lidocaine 4% (Salonpas Pain Relieving Gel-Patch)

• Camphor 3.1% / menthol 6.0% / methyl salicylate 10.0% (Equate Medicated Pain Relief Patches)

Several other brand names are also available. Your pharmacist can help you find an OTC patch that closely matches what you were previously using. Prescription lidocaine patches are also available, such as lidocaine 5% (Lidoderm) and lidocaine 1.8% (ZTlido). Talk to your prescriber about whether one of these alternatives is a good option for you.

Can you get a refund on a recalled patch?

In some cases, you may be able to request a refund for your product. So ask the store or online retailer you bought it from about how they handle drug recalls.

How can you stay up to date on medication patch recalls?

Several resources are available to help you stay informed about drug recalls. You can also check for updates to this particular recall. Some options from the FDA include:

• Recalls, Market Withdrawals, and Safety Alerts page

• Enforcement Reports (which are produced weekly)

• FDA recalls account on X (formerly known as Twitter)

Another option is to sign up to get emails from the FDA, which often contain information about recalls.

Why trust our experts?

Written by:

Amy B. Gragnolati, PharmD, BCPS

Amy Gragnolati, PharmD, BCPS, is a pharmacy editor for GoodRx. Amy currently holds her pharmacist license in Georgia and California.

Reviewed by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

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