The Top 5 Reasons for Drug Recalls and What to Do If You’re Impacted By One

When it comes to your health, it’s important to trust the medications you take. Yet, despite rigorous testing and stringent regulations, drug recalls still happen. From over-the-counter (OTC) staples to life-saving prescriptions, any medication can be subject to a recall.

Some recalls involve minor issues that need to be fixed, such as labeling that doesn’t meet FDA requirements. Others can cause serious harm. But most recalls fall somewhere in the middle — posing a potential health risk with a lower likelihood of serious problems.

Even if you haven’t been impacted by a recall, it’s a good idea to understand why they happen and how to stay informed. Below, we cover the top five reasons for drug recalls and steps you should take if one happens to your medication.

Top reasons for drug recalls

Drug recalls involve the removal of a product from the market for a particular reason. But why exactly do they happen? One study looked at FDA recall information from a 30-month period. The results showed that drug recalls usually fell into one of these five categories.

1. Contamination

When a medication is contaminated, that means it contains something that doesn’t belong. This includes germs, such as bacteria or fungi, heavy metals, and even other medications. Foreign matter, such as glass particles, are another potential contaminant.

Oftentimes, medications are recalled as a precaution due to concerns of potential contamination. The FDA may recommend a recall if it sees unsanitary conditions at the manufacturing facility, especially if the products are supposed to be sterile (completely free of germs). This was the case with the recent artificial tears recall.

One study found that sterility concerns are the most common reason why compounded medications — such as custom-made injections and eye drops — are recalled. In fact, the study found that about 45% of recalls from 2012 to 2021 were from compounding pharmacies.

While they aren’t considered to be drugs, dietary supplements may also be recalled due to contamination concerns. These products can be particularly risky since they aren’t regulated the same way as medications. For example, the FDA found salmonella in test samples of kratom products, which prompted a recall in 2018.

Other recalls related to contaminants include benzene in certain hand sanitizers and aerosol sprays. And higher levels of nitrosamine impurities have resulted in several oral medications being recalled. Benzene and nitrosamines are both found in the environment, but they can increase the risk of cancer at high levels and after long-term exposure.

2. Mislabeling

Mislabeling can result in inaccurate, misleading, or missing information on a drug label or packaging. This can be serious, resulting in someone taking the wrong medication or dose. Examples of drug mislabeling issues that could prompt a recall include:

• Missing label

• Label placed on wrong drug (such as an ibuprofen bottle labeled as aspirin)

• Wrong amount or concentration of drug on the label

• Amount or concentration is expressed in a confusing way

Before taking a medication, it’s a good idea to inspect it closely. Take note of any differences in color, markings, and shape. Look for any inconsistencies on the label. Keep in mind that if you receive a medication from a different generic manufacturer, it may look different. But it doesn’t hurt to double-check with your pharmacist.

3. Adverse reactions

Adverse reactions are unexpected and negative responses that happen after taking a medication. They’re different from side effects, which tend to be more predictable.

Researchers can get an idea of a medication’s potential side effects when it goes through clinical trials. But once the medication is on the market, more people start taking it and less-common adverse reactions may surface.

Recalls due to adverse reactions are relatively uncommon compared with other recall reasons. Instead, an adverse reaction may result in additional warnings or restrictions added to the medication’s label. But a few examples of adverse reactions that have prompted recalls include:

• Loss of smell after using the product

• Serious brain infections

• Increased risk of serious cardiovascular events, such as heart attack and stroke

If you experience an adverse reaction from a medication, contact your prescriber right away. You can also report it to MedWatch, the FDA’s voluntary reporting system. MedWatch helps the FDA track potential safety issues related to medical products.

4. Defective product

If a medication is defective, it may not work as intended. For instance, a medication’s delivery system may have an issue or the container may be defective. Examples of defective product issues include:

• Device doesn’t release the medication properly

• Clogged needles on injection pens and syringes

• Improperly sealed or damaged bottles, blister packs, or pouches

• Missing tamper evident ring

• Problems with adhesive liners on transdermal patches

As mentioned above, it’s a good idea to inspect your medication (including its container) closely before taking it. If the container is damaged, for example, moisture can enter and affect your medication.

Multi-dose injection pens, inhalers, and nasal sprays often require priming before use. This includes test sprays for inhalers and nasal sprays, or releasing a small amount of liquid from the injection pen. Priming can also help you catch issues such as clogged needles or sprayer problems.

5. Incorrect potency

Drug potency issues can result in people receiving lower or higher amounts of a medication than expected. A lower amount can make the medication less effective. And a higher amount can increase the risk of side effects.

Potency issues are often found through routine testing by the manufacturer or the FDA. One example of this is NP Thyroid, which was recalled when the manufacturer identified subpotent (less potent) tablets during testing.

EXPERT PICKS: WHAT TO READ NEXT

• 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.

• Knowing the difference: Learn what sets side effects and adverse reactions apart from one another.

• Seal of approval: The FDA is a government agency that’s tasked with protecting public health. But you may be surprised to learn what the FDA’s responsibilities actually include.

Steps to take if you’re impacted by a drug recall

If you’re impacted by a drug recall, the first step is to ensure that you’re informed. This includes understanding which specific products were recalled and why. Here’s a few things you can do:

• Check your lot number: Each medication package should have a lot (or batch) number on it. A drug recall may only affect certain lot numbers. Check to see if your product is on the list. If you can’t find a lot number, call the pharmacy that dispensed the medication for this information.

• Contact your pharmacy: If your lot number is on the recall list, your pharmacy may be able to get you a replacement medication from an unaffected lot. Your pharmacist can also suggest alternatives if you were taking an OTC product that was recalled.

• Contact your prescriber: Recalls may involve minor issues. Sometimes, the risk of stopping the medication outweighs the risks associated with the recall. Your prescriber may have you continue the medication, stop taking it, or switch to another treatment.

• Dispose of the recalled medication: If you’ve been instructed to stop the medication, be sure to dispose of it properly. If you purchased an OTC product that was recalled, some retailers may have you return the product for a refund.

When it comes to a recall, make sure to follow your healthcare team’s instructions. Tell them right away if you think you might be experiencing side effects from the recalled medication. Get immediate medical attention if any symptoms are severe or feel life-threatening.

How to stay informed about drug recalls

Not all recalls are announced to the public. But the manufacturer, the FDA, or both will usually make an announcement if the issue could significantly impact public health or cause harm.

There are a few different resources available to stay informed about drug recalls. These include:

• Subscribing to FDA mailing lists: Sign up to receive emails from the FDA about recalls, market withdrawals, and safety alerts. You can also sign up for the FDA Enforcement Report mailing list, which provides updates on new and current recalls that the FDA is monitoring.

• Checking the FDA website: Visit the FDA Recalls, Market Withdrawals, and Safety Alert page for recall information. You can also check the weekly Enforcement Report page for a more complete list of recalls.

• Calling the FDA: If you have any questions about whether or not a medication has been recalled, you can contact drug information pharmacists at the FDA. You can reach them by email at druginfo@fda.hhs.gov or by phone at 1-855-543-3784.

• Following the FDA on social media: You can follow the FDA on X (formerly Twitter) for recall updates.

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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:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

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