What FDA's Class II drug recall records show

FDA posted 212 drug recall records in its weekly Enforcement Reports between July 30 and Oct. 28, 2026. Nineteen were Class I, the most serious tier, 15 were Class III and one had not yet been classified. The other 177, or 83 percent, were Class II.

That proportion is normal. In the regulation that sets up the three tiers, 21 CFR 7.3⁴, Class II covers products whose use "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." An openFDA count by classification¹ puts 14,602 of the 18,076 drug recall records since June 2012 in Class II, or 80.8 percent.

Because Class II is most of the file, it is where trends in drug quality show up first. GxRadar pulled all 14,602 Class II records from the openFDA drug enforcement data¹, which run through Oct. 28, 2026, and counted them by year, by recall event and by the reason FDA wrote first. Three findings stand out. Class II events reached a high of 263 in 2025. Manufacturing-practice failures overtook sterility as the most common reason after 2017. And a second wave of nitrosamine recalls, involving a different set of drugs, peaked in 2025.

Records swing, events hold steady

Each record in the file is one product. A pharmacy that recalls every compounded product it made in a year can add hundreds of rows in one week. GxRadar also counted distinct recall events, placing each in the year its first Class II record was reported.

Source: GxRadar analysis of openFDA drug enforcement records, by Enforcement Report date. Events total 2,994. Yearly record counts match an openFDA count of Class II records by report date¹.

Record counts ranged from 483 to 1,780 a year. Event counts stayed between 143 and 263. The 2015 record total, the highest in the data, came largely from two events: 470 records for bulk drug ingredients repackaged in a facility that also handled penicillin, and 382 compounded products recalled for lack of sterility assurance. In 2024 the pattern ran the other way, with fewer records than any other full year but 221 events.

FDA's own count, which uses a different method, points the same way. The agency's FY2024 Report on the State of Pharmaceutical Quality² found 260 recall events in fiscal 2024, "15% more recall events than in FY2023," while "the number of recalled products per event in FY2024 was the lowest in five years." That report leaves out 503B outsourcing facilities, which compound drugs in bulk, and medical gas makers.

The reasons FDA writes first

Each recall record carries a free-text reason, and most begin with a standard phrase followed by details. GxRadar counted the opening phrase of each Class II event. Variant spellings are counted separately, so "lack of sterility assurance" (46 more events) and "CGMP deviation" in the singular (31 more) sit outside the top lines below.

Source: GxRadar analysis of openFDA Class II drug recall records, June 2012 to Oct. 28, 2026.

Sterility dominates by records, and manufacturing practice dominates by events. A full-text openFDA search finds the phrase "lack of assurance of sterility" in 5,333 Class II records¹, many from compounding pharmacies that recalled whole product lines at once. The phrase "CGMP deviations," which FDA uses when a product was made outside current good manufacturing practice, appears in 3,239 Class II records¹. Our explainer on CGMP covers what those rules require.

Lab test failures make up the next tier. "Failed dissolution specifications," a result of the lab check described in our dissolution testing explainer, turns up in 237 Class II records¹, and "subpotent" in 401¹. These problems tend to be caught in a manufacturer's own stability program. Of FY2024's failed-specification recalls, FDA's quality report said most "were discovered during stability testing," with impurities above limits making up 46 percent and dissolution failures 36 percent.

How the mix has shifted

To see change over time, GxRadar searched each Class II event's reason for five recurring themes. A single event can match more than one.

Source: GxRadar keyword search of openFDA Class II event reasons, by year of first report. CGMP counts only reasons that open with that phrase.

CGMP-deviation events ran at 7 to 13 a year from 2013 through 2016, then climbed to 66 in 2018 and 93 in 2020. The data do not say why. Dissolution failures ranged from 9 to 20 events a year through 2024, then reached 24 in 2025 and 25 in 2026 with two months left. Sterility events fell to 14 in 2020 and ran in the 30s for five years before rising to 48 so far in 2026.

Two nitrosamine waves

Nitrosamine impurities "may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time," according to FDA's nitrosamine information page³. The same page says that if drugs contain levels above acceptable daily intake limits, "FDA recommends these drugs be recalled by the manufacturer as appropriate." An openFDA search for Class II reasons naming nitrosamines or the specific compounds returns 463 records¹. GxRadar grouped them into 183 events.

The first wave ran from 2018 to 2020, with 10, 39 and 42 events. Product descriptions in those years name valsartan, losartan, irbesartan, ranitidine and, in 2020, metformin. After falling to two events in 2023, the count rose again, to 17 in 2024 and 42 in 2025. The second wave involves a different chemistry. These are nitrosamine drug substance-related impurities, which form from the drug molecule itself, and the products named include duloxetine, carvedilol, prazosin, chlorpromazine, atomoxetine and cinacalcet. FDA published recommended intake limits for these impurities³ in August 2023 and a revised control guidance in September 2024 with a timeline for manufacturers. The story of the first wave is told in our nitrosamine explainer.

What Class II leaves out

Almost every Class II recall begins with the company. Of the 14,602 records, 14,554 are labelled "Voluntary: Firm initiated" and 29 "FDA Mandated." And 2,418 Class II records were still listed as ongoing on Oct. 28, according to an openFDA status search¹.

For the full recall file across all three classes, see Drug recalls by the numbers and our recall charts. The most serious tier gets its own analysis in What FDA's Class I drug recall records show. New Class II records appear on the GxRadar feed each week. The 2026 count stood at 221 events through Oct. 28, which puts the year on pace to land close to 2025's high.