Drug recalls by the numbers

On March 20, 2019, FDA's weekly Enforcement Report added 465 drug recall entries that all traced back to one recall. Every entry was Class I, the agency's most serious category, and every one gave the same reason, "Microbial contamination." The products were homeopathic liquids, some labeled for teething children, and the recall itself had started eight months earlier, on July 20, 2018.

That single event is why 2019 looks like the worst year for dangerous drug recalls in federal data. FDA's openFDA enforcement API¹ returns 511 Class I drug recall records for 2019, more than three times the count for any other year. Remove the homeopathic event and 46 remain, fewer than in most years.

GxRadar downloaded the full openFDA drug enforcement file, which runs from June 20, 2012, to Oct. 28, 2026, and counted it by year, hazard class, recall event and reason. The same counts feed our recall charts, and the newest entries appear on the GxRadar feed.

One record is one product, and one event can hold hundreds

Each row in FDA's Enforcement Report² is a single product with its own recall number: one strength, one package size, sometimes one batch. A recall event groups every product a firm pulls for the same problem. FDA's openFDA documentation¹ adds that the agency corrects past entries when a firm "may discover that the initial recall should be expanded to include more batches or lots of the same recalled product."

The 18,076 records belong to 4,727 distinct events. The median event has one record, and 3,277 events (69 percent) have exactly one. A few are enormous. Eighteen events produced 100 or more records each, and together they account for 3,596 records, about one in five.

Those big events cluster. In April 2015 a recall of every product repackaged in a facility without adequate separation from penicillin added 470 records. In January 2014 two label mix-up recalls added 273 and 265. In December 2013 a recall of compounded products, after seven reports of skin abscesses linked to an injectable steroid, added 299. One event can even span classes: that 2013 recall holds 297 Class II records and two Class I.

Count events and most of the drama disappears. From 2013 through 2026, distinct events per year stayed between 259 and 392, while records swung from 657 to 2,152.

Source: GxRadar analysis of the openFDA drug enforcement file. Years are the Enforcement Report date. The 2026 total includes one record not yet classified. An event whose records were posted in two different years is counted in both.

Report dates trail the recall

Each year in these counts is the date FDA posted a classified recall, which can come months after a firm starts it. FDA explains on the Enforcement Report page² that "most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health." The homeopathic recall shows the lag: initiated July 20, 2018, classified March 8, 2019, posted 12 days later.

Hazard classes come from FDA's recall definitions³. Class I covers products with "a reasonable probability" of causing "serious adverse health consequences or death." Class II covers temporary or medically reversible harm, or a remote chance of serious harm. Class III covers products unlikely to cause harm at all. Class II made up 80.8 percent of all records, according to an openFDA count by classification¹, with Class I at 9.7 percent and Class III at 9.5 percent. Our explainer on how drug recalls work covers the process in more detail.

The file is also broader than prescription generics. It covers every drug product FDA's drug center oversees, so toothpaste, hand sanitizer⁶, sunscreen and products sold as supplements but found to contain hidden drugs (FDA lists many in its health fraud product database⁷) all appear alongside tablets and injections. Drugs are also a small slice of FDA's recall work overall. The agency's consumer guide to recalls⁸ says more than 83,000 FDA-regulated products of all kinds were recalled between 2014 and 2024.

How GxRadar sorted the reasons

Each record carries FDA's free-text reason for the recall. FDA does not assign reason categories, so GxRadar ran every reason through a fixed list of keyword patterns, in order, and kept the first match: impurities (words such as nitrosamine, NDMA or benzene), then sterility or contamination, labeling or packaging, dissolution, potency, CGMP deviations, other failed specifications, and undeclared or unapproved ingredients. Anything unmatched is "Other."

A keyword sort makes mistakes, and readers should know which ones. A recall for lead in a product lands under sterility or contamination because FDA's text says "chemical contamination." A product stored outside its labeled temperature range can land under labeling because the reason mentions the label. The categories are a rough map of the free text, useful for trends and too blunt for any single recall.

Events are assigned the category of their first record. Our earlier piece on common reasons for drug recalls describes each category in plain terms.

Sterility and contamination account for half of all records, and about two-thirds of those records cite a lack of assurance of sterility, often after an inspection. Dissolution failures look minor by records but rank higher by events, because they usually cover one or two lots of a single tablet or capsule. Impurity recalls show the same pattern, with 699 events behind 1,369 records.

What moved the totals

Three stretches stand out. Sterility and contamination records hit 1,708 in 2015 and 1,532 in 2019, both years shaped by single events described above. Impurity records climbed to 168 in 2018, 215 in 2019 and 137 in 2020 as nitrosamines turned up in blood pressure drugs such as valsartan; 493 records over the whole period name a nitrosamine, either an abbreviation such as NDMA or an "N-nitroso" compound, with 148 of them in 2019 and 104 in 2025. FDA keeps a running page on nitrosamine impurities in medications⁴, and our nitrosamine explainer tells that story.

CGMP deviations then took over, with 261 records in 2021, 515 in 2022 and 327 in 2023. In 2021 and 2022, 474 records from just 16 events cited temperature problems in storage or shipping. FDA's CGMP regulations page⁵ sets out the manufacturing rules those recalls refer to; see also CGMP explained.

Since 2024 the record count has dropped to 657, 765 and 704 (the last through Oct. 28), against an average of 1,411 a year from 2013 to 2023. Events did not fall. There were 311 in 2024 and 327 in 2025, in line with earlier years. What vanished were the giant events: the largest single event held 42 records in 2024 and 27 in 2026.

Almost none of this is ordered by FDA. Of the 18,076 records, 18,012 list the recall as "Voluntary: Firm initiated" and 29 as FDA mandated. The openFDA documentation¹ states plainly that "recalls are almost always voluntary," with FDA overseeing the firm's strategy and assigning the class. Our guide to reading a recall notice explains the fields.

What the latest weeks show

Between July 30 and Oct. 28, 2026, FDA posted 212 drug recall records, 19 of them Class I. Most of those Class I entries were injections and IV solutions with particles found in the liquid, identified variously as glass, stainless steel and plastic. GxRadar looks at that category in its analysis of Class I recall records. The openFDA enforcement data refresh weekly, and the next Enforcement Report will add to all of these counts. Readers checking a specific bottle can use the steps in how to check if your medicine was recalled.