How drug recalls work

Between July 30 and Oct. 28, 2026, FDA's weekly Enforcement Reports carried 212 drug recall product records, 19 of them in Class I, the most serious tier. GxRadar counted them from the openFDA drug enforcement feed¹, which republishes the agency's weekly Enforcement Report. Since June 2012 the same feed has accumulated 18,076 drug recall records.

Almost none of those recalls were ordered by the government. A drug recall is a company removing or correcting a product that FDA considers to be in violation of the law. The company does the work, while FDA classifies the hazard, reviews the plan, checks that it was carried out and publishes the record.

Most of the rules sit in Part 7 of Title 21 of the Code of Federal Regulations², on enforcement policy, and much of it is written as guidance. Knowing how the process runs explains why most recalls never make the news, why a recall's class says nothing about its size, and what the public record can and cannot tell a patient holding a bottle.

Who starts a recall

FDA's drug recall pages³ describe three routes.

• Firm-initiated. Under 21 CFR 7.46⁴, a company may decide on its own to remove or correct a product it has distributed. It is expected to tell FDA promptly and hand over the product details, the reason, a health risk assessment, distribution data and a proposed recall strategy.
• FDA-requested. Under 21 CFR 7.45⁵, the Commissioner or a designee can ask a company to recall a product. The regulation reserves this for urgent situations where a distributed product presents a risk of illness, injury or gross consumer deception, the firm has not acted, and agency action is needed to protect public health.
• FDA-ordered. A recall can also be carried out by FDA order under statutory authority, as FDA's recall background page⁶ notes. For drugs this is rare.

Enforcement data show how lopsided the split is. Of the 18,076 records, 18,012 are labeled "Voluntary: Firm initiated" and 29 are labeled "FDA Mandated." A firm-initiated recall often follows an FDA inspection or test result, so voluntary does not mean the company found the problem alone; our piece on inspections and warning letters covers that side.

Two related actions are not recalls at all. A market withdrawal is removal for a minor violation FDA would not take legal action over, or for no violation. A stock recovery covers product that never left the company's direct control. Neither appears in the Enforcement Report.

Classes I, II and III

Once a recall is under way, FDA evaluates the health hazard and assigns a class under 21 CFR 7.41⁷. The definitions are in 21 CFR 7.3⁸.

A recall's class describes the hazard and says nothing about volume. GxRadar has broken down the Class I and Class II records separately. A Class III recall can cover a large quantity of product with a wrong expiration date on the carton, while a Class I recall can cover a single lot. FDA's consumer guidance on recalls⁹ gives labeling errors, packaging defects and incorrect expiration dates as typical Class III problems.

Record counts need the same caution, because the feed has one row per product and one recall event can generate many rows. In 2019 the data show 511 Class I records, the most of any year, and 465 of them carry the same two-word reason, "Microbial contamination." Grouped by GxRadar into broad categories, sterility and contamination problems account for 9,273 of the 18,076 records since 2012. The full breakdown is on our recalls page and in common reasons for drug recalls.

How a recall strategy is set

Every recall runs on a written strategy for that specific case, and 21 CFR 7.42¹⁰ says it must address three things.

Depth

Depth is how far down the distribution chain the recall reaches. At the wholesale level it stops at distributors. At the retail level it reaches pharmacies and other retailers, including any wholesalers in between. At the consumer or user level it reaches patients, hospitals and other end users. FDA's patient guidance says Class I recalls are generally run at the consumer level, Class II at retail and Class III at wholesale, and the firm and FDA can adjust depth based on the hazard and how far the product traveled.

Public warning

Section 7.42 reserves a press release or other general public warning for urgent situations where other ways of preventing use appear inadequate. FDA says public notice is generally issued for products that are widely distributed or pose a serious hazard. That is why the recall announcements on FDA's site are a small subset of the full record.

Effectiveness checks

The strategy also sets how the firm will prove that the accounts it notified actually received the notice and acted. The regulation defines five levels.

Notices, status reports and termination

Under 21 CFR 7.49¹¹, the recalling firm must promptly notify each affected direct account. The notice should identify the product, explain the reason and give clear instructions on what to do with it. Those accounts are often wholesalers, which pass the notice to pharmacies and hospitals; pharmacies may contact patients when a recall reaches consumer level.

While the recall runs, the firm sends FDA status reports. 21 CFR 7.53¹² says the reporting interval will generally be between two and four weeks.

Status in the Enforcement Report moves through three stages. A recall is Ongoing while in progress and Completed when the firm has recovered what it reasonably can or finished its corrections. It is Terminated when FDA decides that all reasonable efforts to remove or correct the product have been made, under 21 CFR 7.55¹³; our piece on how drug recalls end follows that last step. As of late October 2026, openFDA listed 14,814 drug recall records as terminated, 2,824 as ongoing and 438 as completed.

Where recalls become public

FDA publishes every recall it monitors in its weekly Enforcement Report¹⁴ once the recall has been classified, as 21 CFR 7.50¹⁵ provides. Each entry carries a recall number, the class, a product description, the reason, lot and expiration details, the distribution pattern and a status, fields FDA defines on its Enforcement Report information page¹⁶. Our guide to reading a recall notice walks through a sample entry.

A recall record says that a specific product, in specific lots, failed a specific requirement. It does not say every lot of that medicine is affected, or that other manufacturers' versions share the problem. Many recalls cover a handful of lots out of years of production, which is why GxRadar's guide to checking whether a medicine was recalled turns on the lot number.

FDA's guidance for patients draws its line by class. For Class I recalls it tells patients to follow the recalling company's instructions. For Class II and III recalls, it says⁹ patients can generally keep taking the medicine unless the company or FDA says otherwise, notes that stopping a medicine can sometimes be more harmful than continuing it, and directs anyone with questions to a doctor or pharmacist. New entries reach the openFDA feed weekly, and GxRadar's radar feed picks them up as they post.