When a medicine or medical device is recalled

A drug recall is a company's action to take a defective medicine off the market or to warn patients about a risk. A company may start a recall on its own at any time, or because the Food and Drug Administration (FDA) recommends or requests it. The FDA oversees the company's recall and checks that customers were told and the product was removed. More than 83,000 FDA-regulated products were recalled between 2014 and 2024.

You may hear about a recall in the news or from the drug's maker, your health care provider or your pharmacy. Not every recall is announced on the FDA's website or in the news. Public notices are generally issued when the product was widely distributed or poses a serious health hazard.

The three classes

• Class I is the most serious. Using the drug could cause serious health problems, and the risk is immediate and life-threatening. These recalls are urgent, usually remove the drug from the market and generally reach consumers directly.
• A Class II recall means using the drug could cause temporary health problems, and a serious one is unlikely. You can keep using the medicine unless the recall notice says otherwise.
• A Class III recall means the drug isn't likely to cause health problems, as with a minor labeling error, defective packaging or a wrong expiration date. You can keep using it unless told otherwise.

What you need

• The medicine's bottle or box, with its label
• The recall notice, or the FDA's recall listing for the product
• Your pharmacy's phone number

Steps

1. 1

   Match the lot number

   Find the lot number on your medicine's label and compare it with the lot numbers in the recall notice. Check the product description, package size and expiration date too.

   5 min

2. 2

   Read the class and the instructions

   A Class I notice usually tells patients what to do, and those instructions come first. For Class II and III, you can generally keep taking the medicine unless the company says otherwise.

   5 min

3. 3

   Talk to your doctor or pharmacist

   Stopping a medicine can sometimes be more harmful than taking the recalled one. Ask before you stop, and ask about a replacement.

   10 min

4. 4

   Return it or dispose of it

   Companies may ask you to return a recalled medicine to the place you bought it, and most retailers have return and refund policies for recalled products. If you can't return it, dispose of it properly and don't give it to anyone else.

   10 min

A recalled medical device

A medical device recall doesn't always mean you have to stop using the device or send it back. Sometimes the device only needs to be checked, adjusted or fixed, as with a software update or new instructions for use. Contact your health care provider for what to do with yours.

The most serious device recalls are posted online. So are early alerts when a company takes action on a device that's likely to become one of them.

If a product made you sick

Contact your health care provider about any illness, injury or allergic reaction. You can also report the problem to the FDA through MedWatch, its safety reporting program, online, by phone or by mail or fax. Report it to the company that made the product too.

Hearing about recalls

The FDA keeps a database of recalled medicines with each recall's class and reason, and a list of recalls, market withdrawals and safety alerts across the products it regulates. You can sign up on that list to get daily or weekly recall notices. For medicines you no longer need, see Getting rid of unused medicines safely.