Drug recalls: what to do with recalled medication
Not medical advice. This guide summarizes public information from U.S. government health agencies for general education. It is not a substitute for advice from a doctor, pharmacist or other qualified health professional. If you have symptoms or questions about your health, contact a health professional. In an emergency, call 911.
Finding out that a medicine you take has been recalled can be alarming, especially if you rely on it every day. The most important thing to know up front: do not stop taking a prescribed medicine on your own. The FDA itself warns that stopping a medicine can sometimes be more harmful than continuing to take the recalled product. This guide explains how drug recalls work, how to check your medicine, and what to do next, based on FDA guidance.
How drug recalls work
The FDA describes a drug recall as a voluntary action taken by a company to remove a defective drug from the market or warn patients about a potential risk. A recall can be started by the company at any time, or recommended or requested by the FDA. The FDA's role is to oversee the company's recall strategy, check that customers were properly notified and the product removed, and take further action if a recall is not effective.
Drugs are recalled for many reasons. Recent FDA drug recall announcements have involved particles found in injectable solutions, elevated endotoxin levels, and product mix-ups in which a package may contain a different drug than its label says. Other recalls involve tablets that fail dissolution or stability testing, impurities, or labeling errors.
What the recall class means for you
The FDA assigns every drug recall a class based on risk. Its consumer guide, Understanding Drug Recalls, explains what each one means for patients:
- Class I: The most serious. There is a reasonable probability that using the drug will cause serious health consequences, and the consequences can be immediate and life threatening. Class I recalls are urgent, generally remove the drug from the market, and are generally carried out at the consumer level. These notifications generally include instructions for patients, and the FDA recommends following them.
- Class II: Using the drug may cause temporary health problems, but a serious problem is remote. These recalls are generally conducted at the retail level, and patients can generally continue using the medicine unless the company or FDA directs otherwise.
- Class III: Using the drug is not likely to cause health problems. Examples include minor labeling errors, defective packaging or incorrect expiration dates. These recalls are generally conducted at the wholesale level, and patients can generally continue using the medicine unless told otherwise.
For more on recall classes across food and drugs, see FDA recall classes explained.
How to check if your medicine has been recalled
The FDA says people usually learn about a drug recall through the news, the manufacturer, their health care provider or their pharmacy. To check yourself:
- Find the lot number on your medicine's label, bottle or carton. It is often printed near the expiration date.
- Compare it with the lot numbers listed in the recall notice. Only the listed lots are affected.
- Check the strength and package size, since a recall may cover one strength but not another.
- Ask your pharmacist if you cannot find the lot number. Your pharmacist can help you check.
Keep in mind that the FDA says not all recalls are announced on FDA.gov or in the news. Public notification is generally issued when a widely distributed product, or one that poses a serious hazard, is recalled. All recalls are posted in the FDA enforcement report, which is the source for our drug recalls page.
What to do if your medicine is recalled
- Do not panic and do not stop on your own. Call your pharmacist or doctor. They can tell you whether to keep taking it, and can often switch you to a different lot or an alternative.
- Follow the company's instructions for Class I recalls.
- Return or exchange it. The FDA notes that companies may advise returning recalled medicine to the place of purchase, and most retailers have return and refund policies for recalled products.
- Watch for problems. If you think the medicine made you sick, contact your health care provider. In an emergency, call 911.
- Report problems. Patients and consumers can report side effects and quality problems to the FDA through MedWatch.
Supplements with hidden drug ingredients
Some recalls involve products sold as dietary supplements, such as weight-loss or sexual enhancement products, that contain undeclared drug ingredients. If you take a product like this, stop using it and talk to a health care provider, especially if you take other medicines. You can follow these on our supplement recalls page.
How to dispose of recalled medicine safely
If the recall notice or your pharmacy gives return instructions, follow those first. Otherwise, the FDA's disposal guidance says:
- Best option: take it to a drug take-back location (often at a pharmacy or police station) or use a prepaid drug mail-back envelope.
- If take-back is not available: check the FDA flush list. Flush only medicines that are on that list.
- Otherwise, use the trash: mix the medicine (without crushing pills) with something unappealing such as dirt, cat litter or used coffee grounds, seal it in a plastic bag and throw it away. Scratch out personal information on the empty package.
Some products, such as sprays or needles, have their own disposal instructions; ask your pharmacist.
Stay informed
Drug recalls can be hard to follow because many never make the news. Checking a source that lists all FDA enforcement reports, or signing up for an email digest, is the most reliable way to keep up.
Frequently asked questions
Should I stop taking a medicine that has been recalled?
Not without advice. The FDA says that in some instances stopping your medicine may be more harmful than continuing to take the recalled medicine. For Class II and III recalls, consumers can generally keep taking the medicine unless the company or FDA says otherwise. For Class I recalls, follow the recalling company's instructions. Talk to your pharmacist or doctor before stopping.
How do I know if my medicine is part of a recall?
Check the lot number on your medicine's label and compare it with the lot numbers in the recall notice. The FDA says only the lots listed are affected. Your pharmacy can also tell you whether your prescription came from a recalled lot.
Are all drug recalls announced in the news?
No. The FDA says not all recalls are announced on FDA.gov or in the news. Public notification is generally issued when a widely distributed product or one that poses a serious hazard is recalled. All recalls are posted in the FDA enforcement report, which Recall Radar summarizes.
How do I get rid of recalled medicine?
First follow any return instructions in the recall notice or from your pharmacy. Otherwise, the FDA says the best option for most medicines is a drug take-back location or a prepaid mail-back envelope. If neither is available, check the FDA flush list; if the medicine is not on it, mix it with something unappealing like used coffee grounds or cat litter, seal it in a plastic bag and put it in the trash.
Where do I report a problem with a medicine?
You can report side effects or quality problems with medicines to the FDA's MedWatch program, which accepts reports from patients and consumers as well as health professionals.