In 1982, seven people died when an unknown person placed cyanide into bottles of Tylenol in Chicago. Johnson & Johnson responded by recalling every product that contained acetaminophen throughout the U.S. It was the largest nationwide drug recall in history and changed how recalls are handled.

If you are wondering how to handle medication recalls, the first steps are to stop using the recalled drug, return any unused medication to the pharmacy or place of purchase, follow the recall instructions, and talk to your doctor before stopping any prescription medication. For anyone who has used or bought a prescription or over-the-counter drug and is now concerned about safety, it helps to understand what a recall means, why the FDA announces recalls, how recalls are classified, what consumer safety steps to take, and when a recalled medication injury may call for legal help.

Today’s drug recalls are usually less dramatic than the Tylenol case, but they still affect patient safety and public health. Knowing how to respond can reduce the risk of harm from a defective or dangerous drug and help you protect your rights if the recall is tied to a serious injury.

What Are Drug Recalls and the Role of the Food and Drug Administration?

The Food and Drug Administration (FDA) and drug manufacturers must cooperate in drug safety, and regulatory authorities must be promptly notified when a recall begins. A drug recall occurs when the manufacturer pulls a prescription or over-the-counter (OTC) medication from the market, and an FDA recall of prescription medications is one part of the broader drug recall process. Drug recalls are voluntary, and the FDA has the authority to order the recall of certain medical devices, but for drugs the FDA generally can only request a recall rather than mandate one. FDA drug recalls are not mandatory, but the FDA can bring government regulators into the case.

A drug recall means that the drug can no longer be sold, and the product is removed from all pharmacies, hospitals, and other places where recalled products or recalled medications are administered or sold. A recall notice is provided to the public to inform patients and healthcare professionals what product is involved and what action to take, including whether to destroy or return any unused medication, and pharmacies, healthcare professionals, and consumers are notified through clear, actionable recall communications. In addition, if the recall is due to harmful effects or dangerous drug interactions, the notice may advise patients to seek medical care.

Why Are Drugs Recalled?

A pharmaceutical company may recall drugs for several reasons, and recall procedures can begin for quality issues or risks that may cause harm. These can be as simple as mislabeling or improper packaging or as serious as potentially fatal adverse reactions. Some of the most frequent causes of voluntary recall include:

  • Poor labeling. If the labeling is misleading or confusing, it can be recalled. If the instructions for a dose are unclear or could lead to improper use of the medication, then the medication will be pulled.

  • Poor or improper packaging. A mistake in packing can lead to immediate recall. For instance, if the box says the medicine is a pain reliever, but the medicine inside is an antihistamine, it must be recalled.

  • Manufacturing error or contamination. If problems during manufacture lead to harmful substances contaminating the medication, or incorrect fillers being used, the drug will be recalled. For instance, certain inert binding agents cannot be used in some medicines even though they are not harmful by themselves.

  • Quality control. Sometimes a batch recall may be issued because it does not meet quality control standards, and the affected lot is identified by batch information and recall date. There may be nothing harmful about the product, but it is not up to the company's requirements.

In cases with more serious issues, the Federal Drug Administration (FDA) will formally request the company to recall all the drugs even if all the other conditions are acceptable.

Adverse Reactions

An “adverse reaction” is an undesirable, unexpected, or dangerous effect caused by medication, and serious adverse events can also trigger reporting and recalls. An adverse reaction differs from a “side effect” in being more harmful or less controllable, and some reactions can be life threatening. An "allergic reaction" may be an adverse or a side effect, depending on the nature of the reaction. For instance, sneezing may be a side effect, but anaphylaxis would be an adverse reaction.

Side effects are sometimes secondary effects, whereas adverse reactions are effects that were not anticipated by the use of the drug. Adverse reactions will lead to drug recalls.

Potential Risks of Recalled Medications

The FDA may request a manufacturer recall a product when there is a risk of illness, injury, or deception, even if no other adverse reactions have been reported, to protect patient safety and public health. The FDA may have received complaints from consumers or reports from healthcare providers through a reporting system, including vaccine-related concerns, or conducted proprietary research, even if the manufacturer has not initiated a recall.

Recall Classifications

The FDA developed a series of guidelines for companies to follow as part of the FDA recall process for a drug or medical product (21 CFR 7). This includes a series of classifications to help determine how serious a recall should be, who is involved, and what alert or notice should be sent:

Class I:

There is a reasonable probability that the product will cause serious injury, life-threatening injury, or death, creating a serious risk of harm. Recalls have included pacemakers, heart valves, and lifesaving drugs.

Class II:

Most recalls are a Class II recall. The drug or device may cause temporary or medically reversible adverse effects. For example, knee and hip implant failures fall into this category rather than causing permanent injury.

Class III:

A Class III recall means the product is unlikely to cause injury. OTC medications, packaging errors, and container defects are Class III recalls.

Consumer Safety

If you hear about medical devices or drugs recalled by FDA, don't panic. Most medication recalls are minor and involve packaging or labeling issues. Here are the steps you should take at the consumer level if you learn of a drug recall, because quick action is vital for patient safety when recalled medications are identified.

If the drug is an OTC medication, stop taking it. Return it to where you purchased it, speak to the pharmacist, and request a refund. The pharmacist may need to return the product to the manufacturer, and there is often a store refund policy for drug recalls.

If the drug is a prescription drug, call your doctor immediately. You should never stop taking a drug without speaking to healthcare professionals. Ask what you need to do, and they should inform you whether to continue or stop therapy. You may need a new prescription or an alternate medication.

If you have purchased a medication of any kind and notice an unusual smell, appearance, or color in the medication before you take it, don't use it. Contact the pharmacy right away to see if the medication has been recalled and return the package to the pharmacy. Check the recall date and any lot details before returning the product. Never use an unlabeled product or unpackaged medication.

Never flush suspect or unused medication down the toilet or throw it away. Return it to the pharmacy for disposal. Pharmacies may use an internal alert system so a recalled dose is not dispensed again.

When Should You Hire a Lawyer?

If you have used a drug or other defective product that was the subject of a Class I recall, you need the services of a medical malpractice attorney immediately. These cases can involve harm to life and create urgent legal responsibility for the parties involved. Drug recall cases are subject to statutes of limitation, and the notice of the recall starts the clock running.

If you believe you have used a medication that was recalled and you are unsure if there has been a recall, all recalled drugs and devices are listed on the FDA recall list on the FDA's website. The FDA recall process tracks recalled products by date, with separate listings for food, drugs, medical devices, and other FDA-regulated products.

You should contact a drug recall attorney if a medication or medical device injured you. Your time to file a lawsuit is limited, and gathering the information will take time. Prompt legal review is especially important if serious adverse events were reported. Contact Ratzan Weissman & Boldt for a free and confidential review of your case. Our attorneys will let you know the best way to proceed. Contact us today.