Goodbye Red Dye: How the FDA’s Ban on Red Dye 3 Impacts Your Medications

In January 2025, the FDA banned FD&C Red No. 3 (Red Dye 3, erythrosine), a color additive found in foods and oral medications. This decision was in response to a 2022 petition to remove it from these products. Many consumer advocates see this as a positive move forward for public health. But it also raises questions for those who rely on medications containing Red Dye 3.

Red Dye 3 has long been used to enhance the appearance of medications, making them more visually appealing or helping to distinguish dosages. It was banned in cosmetics and topical medications decades ago. But its use in foods and oral medications were allowed to continue — until now. 

Below, we explore why the FDA made this decision, identify which medications are affected, and discuss what it means for you.

What is Red Dye 3, and why is it used in medications?

Red Dye 3 is a synthetic (human-made) color additive that gives medications a bright red or pink hue. It may be found in dosage forms such as:

• Liquid medications, like cough syrups

• Chewable tablets for vitamins or allergy relief

• Coated tablets for over-the-counter (OTC) and prescription medications

These visual enhancements make medications easier to identify or help differentiate between dosages. However, concerns about its safety have persisted for decades.

Why is Red Dye 3 being banned?

The FDA decided to ban Red Dye 3 for legal reasons. FDA regulations, specifically what’s known as the Delaney Clause, require the banning of any additive shown to cause cancer in humans or animals, no matter the dose.

Animal studies have linked Red Dye 3 to thyroid tumors. But this, the FDA explains, doesn’t necessarily mean that Red Dye 3 causes cancer in humans:

• The animal studies were done in male rats exposed to large amounts of Red Dye 3. In one study, this amount was 4% of their diet over their lifetime. This is far greater than the amount that humans are exposed to.

• The way that Red Dye 3 causes cancer in male rats is specific to rats. It doesn’t occur in humans.

• Studies in other animals and humans haven’t shown the same cancer risk.

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Christina Madison, PharmD, founder and CEO of The Public Health Pharmacist, told GoodRx that the ban on Red Dye 3 “specifically applies to any food or ingested drugs that use it for manufacturing.” According to the FDA, manufacturers must phase out Red Dye 3 from foods by January 15, 2027, and from oral medications by January 18, 2028.

Why wasn’t Red Dye 3 banned in medications earlier?

Red Dye 3 has been banned for use in topical medications since 1990. This was after animal studies in the 1980s showed a cancer risk. And as a result, the FDA intended to ban it in oral medications around that time, too.

But given the resources required for this task, the FDA didn’t move forward at the time. It wasn’t until 2022 when a group of 24 organizations and scientists submitted a petition to remove Red Dye 3 from these products. In response, the FDA decided to ban the additive to comply with their own regulations.

Which medications contain Red Dye 3?

Even though the FDA has announced a ban on Red Dye 3 in oral medications, manufacturers have until 2028 to reformulate their products. “Since there is still time before these products are required to be reformulated, the dye is still present in some drug products,” said Madison.

To find out if your medication has Red Dye 3, you can:

• Check the label: Inactive ingredients such as “Red No. 3,” “Red 3,” or “FD&C Red No. 3” will be listed. You can find this on the Drug Facts label on OTC medications.

• Ask a healthcare professional: Your pharmacist can confirm if a medication contains Red Dye 3. You can also call the medication’s manufacturer, which should be listed on your prescription label. They usually have a customer service number that you can find online for assistance.

It isn’t comprehensive, but a few examples of oral medications with Red Dye 3 are included in the chart below:

*The information in this table is based on package inserts last updated in 2023, 2024, or 2025. The manufacturer or your pharmacist can confirm the specific ingredients in your medication based on the date they were manufactured.

Keep in mind: Just because a medication looks red or pink, doesn’t mean it contains Red Dye 3. Many contain a different color additive, such as Red Dye 40, instead. The FDA currently considers Red Dye 40 safe in small amounts. But there has been ongoing research and debates as to whether it also has health risks.

What is the exposure risk from medications with Red Dye 3?

The FDA’s decision to ban Red Dye 3 is precautionary and based on legal requirements. As covered above, the same cancer risks in male rats haven’t been seen in humans. Even so, it’s understandable to be concerned about exposure.

When it comes to Red Dye 3 in oral medications, the actual exposure risk is likely low due to the small amounts used in these products. But it’s important to keep in mind that this ingredient isn’t just in medications. It’s also found in some foods, which may be easier to avoid. Look for the ingredient list under the nutritional label to find this information.

What should you do if your medication contains Red Dye 3?

If you find that your medication contains Red Dye 3, don’t stop taking it without talking to your healthcare team. Some medications can have dangerous effects if you stop taking them abruptly. Instead, talk to them about your concerns and potential options. Keep in mind that the ban is precautionary and doesn’t mean Red Dye 3 causes cancer in people.

If you want to avoid Red Dye 3 before it’s phased out, your healthcare team can help. If you’re taking a generic, for example, your pharmacist may be able to switch you to a different manufacturer that doesn’t use this additive. Switching to a different manufacturer may not be possible for brand-name medications. In this case, your prescriber can discuss potential alternative medications.

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Written 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.

Reviewed by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

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