Can the FDA force a company to recall a drug?

Not usually. For most prescription and over-the-counter drugs, the FDA's mandatory recall authority is narrow and mainly reserved for categories like biological products and infant formula. In practice, the FDA requests recalls and applies pressure through inspections and public communication, and manufacturers almost always recall voluntarily once a problem is confirmed.

Are dietary supplements regulated the same way as drugs?

No. Under the Dietary Supplement Health and Education Act, supplements are legally treated as a category of food, not a drug, so they don't need FDA approval before going on sale. That also means the FDA's mandatory recall authority over food, granted by the FDA Food Safety Modernization Act, extends to supplements, giving the agency a stronger backstop here than it has for ordinary drugs, even though most supplement recalls still happen voluntarily.

What did the MoCRA law change for cosmetic recalls?

MoCRA, which became law in December 2022, required cosmetic facilities to register with the FDA, required companies to list their products, and introduced mandatory serious adverse event reporting. It also gave the FDA a new, limited power to order a mandatory recall of a cosmetic that poses a reasonable probability of serious health consequences if the company refuses to recall it voluntarily, a power the FDA did not have over cosmetics before.

What's a Class I drug recall?

A Class I drug recall is the most serious category, used when there's a reasonable probability that using the product will cause serious adverse health consequences or death. Examples include sterile injectable drugs contaminated with microbes or particulate matter, and products mislabeled with the wrong strength or the wrong medication entirely.

What should I do if my prescription medication is recalled?

Talk to your doctor or pharmacist before stopping it. Stopping some medications abruptly carries its own health risks, and your doctor or pharmacist can tell you whether an unaffected lot, a replacement supply, or an alternative medication makes sense. For over-the-counter drugs and supplements, it's generally safe to simply stop using the product and follow the remedy in the recall notice.

How do I find out if a medication, supplement, or cosmetic I use has been recalled?

RecallRadar's search covers FDA drug enforcement reports alongside related CPSC recalls, and the Health & Cosmetics category at /category/health-cosmetics groups recent recalls in that space. You can also report a reaction you've had to a recalled product through the FDA's MedWatch program.

FDA Drug and Cosmetic Recalls: How They Work and Why They Differ From Food

By the RecallRadar team · Updated November 2, 2026

When people think about recalls, they usually picture a toy, a car seat, or a bag of lettuce. The medicine cabinet and the bathroom shelf get a lot less attention, even though prescription drugs, over-the-counter medications, dietary supplements, and cosmetics all get recalled too, and the rules governing those recalls are different from the ones that apply to food. The FDA oversees all of these product types, but Congress gave the agency a different set of legal tools for each one, which means a recall notice for a blood pressure medication, a protein powder, and a sunscreen can look and work in genuinely different ways even though all three come from the same federal agency.

That patchwork isn't obvious until you need it to make sense, usually right when a notice shows up for something you actually use. This guide walks through how drug recalls work, why most of them are voluntary, what changed recently for cosmetics, how the FDA's severity classifications apply outside of food, and what to actually do if a medication, supplement, or personal-care product in your home turns up on a recall list.

Three Shelves, Three Different Rulebooks

Prescription and most over-the-counter drugs go through premarket review before they can be sold, meaning a company has to show the FDA evidence of safety and effectiveness first. Dietary supplements work almost the opposite way. Under the Dietary Supplement Health and Education Act of 1994, usually shortened to DSHEA, supplements are legally treated as a category of food rather than a drug, so a manufacturer can generally bring one to market without FDA approval and without proving effectiveness ahead of time. The FDA's role with supplements is mostly after the fact: monitoring labeling, investigating adverse event reports, and inspecting manufacturing facilities.

Cosmetics sat in the loosest category of the three for decades. Until recently, federal law gave the FDA very limited authority over everyday products like lotions, shampoos, makeup, and skin creams, no premarket approval, no mandatory registration, and no general power to order a recall. That gap is a big part of why cosmetic recalls have historically felt less structured than drug or food recalls, and it's also why a 2022 law changed the picture meaningfully, which the next section covers.

Why Most Drug Recalls Are Voluntary

For ordinary prescription and over-the-counter drugs, the FDA generally does not have broad authority to order a company to recall its product. The agency can request a recall, inspect a facility, publish a public warning, and apply significant pressure, but outright mandatory recall power for standard drugs is narrow and mostly reserved for specific categories like biological products and infant formula. In practice, this rarely matters for how a recall unfolds: once a manufacturer discovers a problem, through its own quality testing, an inspection finding, or a pattern of adverse event reports, it almost always initiates the recall voluntarily and works with the FDA on classification, public notices, and follow-up.

The FDA's MedWatch program is the main channel for reporting problems with drugs and other FDA-regulated medical products after they're on the market. Consumer and healthcare provider reports submitted there feed directly into the kind of safety signal that can prompt a company, or the FDA, to take a closer look at a product already in circulation.

Dietary Supplements Sit in Their Own Gray Zone

Because DSHEA treats supplements as a category of food rather than a drug, the FDA's food-related recall authority actually applies to them. The FDA Food Safety Modernization Act, passed in 2011, gave the agency the power to mandate a recall of food, including supplements, when a company refuses to recall voluntarily and there's a reasonable probability the product could cause serious health consequences. That's a stronger backstop than the FDA has for ordinary drugs.

Even so, most supplement recalls play out the same way most food and drug recalls do: voluntarily, after a problem surfaces. Common findings include contamination, mislabeled or inconsistent ingredient amounts, and in some cases undisclosed pharmaceutical ingredients quietly mixed into products marketed for weight loss, bodybuilding, or sexual enhancement, which the FDA has flagged as a persistent problem in parts of the supplement market.

What Changed for Cosmetics: The MoCRA Law

The Modernization of Cosmetics Regulation Act, generally referred to as MoCRA, became law in December 2022 and is the first major expansion of the FDA's cosmetic authority in decades. It requires cosmetic manufacturing facilities to register with the FDA and to submit product listings, and it requires companies to report serious adverse events linked to their products within a set timeframe rather than leaving that reporting entirely voluntary.

The most significant change for recalls specifically is that MoCRA gives the FDA a new, though still limited, mandatory recall power for cosmetics. If a cosmetic product poses a reasonable probability of causing serious adverse health consequences and the company declines to recall it voluntarily, the FDA can now order the recall directly. In practice, voluntary recalls initiated by the company remain the norm, the same way they do for drugs and supplements, but the backstop that didn't exist before now does.

How Severity Classification Works Outside of Food

The FDA uses a three-tier classification system for drug recalls that mirrors the one it uses for food, even though the underlying products and hazards are different. Class I is reserved for situations where there's a reasonable probability that using the product will cause serious adverse health consequences or death. For drugs, that can mean a sterile injectable contaminated with microbes or visible particulate matter, a product that was mislabeled with the wrong strength or the wrong drug entirely, or a defect that could cause a life-threatening dosing error.

Class II covers problems that are more likely to cause a temporary or medically reversible issue, or where a serious outcome is only a remote possibility, such as a tablet that fails a dissolution specification without posing an acute danger. Class III is reserved for labeling or manufacturing violations that aren't expected to cause any adverse health consequences at all, like a packaging insert with outdated contact information. Cosmetic recalls under MoCRA are new enough that formal classification hasn't become as standardized in public reporting as it has for drugs and food, but the FDA still weighs severity when deciding how urgently to describe a hazard and how publicly to communicate about it.

Common Reasons These Products Get Recalled

A handful of recurring issues account for most recalls in this space, whether the product is a prescription drug, a supplement, or a cosmetic.

Microbial contamination, which is a particular concern in liquid or cream-based products like eye drops, lotions, and injectable drugs
Particulate matter or dosing errors in injectable or oral medications
Undeclared or banned ingredients, including undisclosed pharmaceutical ingredients in some supplements and prohibited substances in some imported skin-care products
Packaging that fails to meet child-resistant requirements for products covered by the Poison Prevention Packaging Act
Labeling errors, including incorrect strength, missing warnings, or mixed-up product lines coming off the same manufacturing equipment

What to Do If a Medication, Supplement, or Cosmetic You Use Is Recalled

If a prescription medication you take is recalled, don't just stop taking it on your own. Talk to your doctor or pharmacist first, since abruptly stopping some medications carries its own risks, and they can tell you whether an unaffected lot, a different supply, or an alternative is the right next step. For over-the-counter drugs, supplements, and cosmetics, the usual approach is simpler: stop using the product, check the lot or batch number on the package against the recall notice, and follow the remedy it describes, which is typically a refund, a replacement, or instructions for safe disposal.

If you've already had a reaction to a recalled drug, supplement, or cosmetic, report it through the FDA's MedWatch program. Those reports are one of the main ways the FDA and manufacturers learn that a problem exists in the first place, so they matter even when the reaction itself was mild.

RecallRadar's search and the Health & Cosmetics category at /category/health-cosmetics bring together FDA drug enforcement reports alongside CPSC recalls for health-related devices like thermometers, massagers, and CPAP equipment, refreshed every six hours from the underlying agency data. Checking there, or searching for a specific brand or product name, is faster than trying to track multiple agency feeds separately.

Frequently asked questions

Can the FDA force a company to recall a drug?: Not usually. For most prescription and over-the-counter drugs, the FDA's mandatory recall authority is narrow and mainly reserved for categories like biological products and infant formula. In practice, the FDA requests recalls and applies pressure through inspections and public communication, and manufacturers almost always recall voluntarily once a problem is confirmed.
Are dietary supplements regulated the same way as drugs?: No. Under the Dietary Supplement Health and Education Act, supplements are legally treated as a category of food, not a drug, so they don't need FDA approval before going on sale. That also means the FDA's mandatory recall authority over food, granted by the FDA Food Safety Modernization Act, extends to supplements, giving the agency a stronger backstop here than it has for ordinary drugs, even though most supplement recalls still happen voluntarily.
What did the MoCRA law change for cosmetic recalls?: MoCRA, which became law in December 2022, required cosmetic facilities to register with the FDA, required companies to list their products, and introduced mandatory serious adverse event reporting. It also gave the FDA a new, limited power to order a mandatory recall of a cosmetic that poses a reasonable probability of serious health consequences if the company refuses to recall it voluntarily, a power the FDA did not have over cosmetics before.
What's a Class I drug recall?: A Class I drug recall is the most serious category, used when there's a reasonable probability that using the product will cause serious adverse health consequences or death. Examples include sterile injectable drugs contaminated with microbes or particulate matter, and products mislabeled with the wrong strength or the wrong medication entirely.
What should I do if my prescription medication is recalled?: Talk to your doctor or pharmacist before stopping it. Stopping some medications abruptly carries its own health risks, and your doctor or pharmacist can tell you whether an unaffected lot, a replacement supply, or an alternative medication makes sense. For over-the-counter drugs and supplements, it's generally safe to simply stop using the product and follow the remedy in the recall notice.
How do I find out if a medication, supplement, or cosmetic I use has been recalled?: RecallRadar's search covers FDA drug enforcement reports alongside related CPSC recalls, and the Health & Cosmetics category at /category/health-cosmetics groups recent recalls in that space. You can also report a reaction you've had to a recalled product through the FDA's MedWatch program.