Class III recalls: what the data show

On Oct. 28, 2026, FDA's weekly Enforcement Report⁸ carried a Class III recall of a combination blood pressure tablet containing telmisartan and amlodipine. The stated reason was "potential for the Telmisartan content in these lots to exceed specifications." It was one of 54 Class III drug recall records posted in 2026 through that date.

Class III is the lowest of FDA's three hazard tiers. Under 21 CFR 7.3¹, it covers "a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences." A Class I recall, by contrast, involves "a reasonable probability" of serious harm or death, and Class II sits between them, with harm that is temporary or medically reversible, or a remote chance of anything serious. FDA's recall definitions page⁵ uses the same wording.

Class III recalls rarely make news, but they make up a steady slice of the record and say a good deal about routine quality control. GxRadar pulled all 1,720 Class III records from the openFDA drug enforcement data⁶, which run from June 20, 2012, through Oct. 28, 2026, and sorted them by year, recall event and reason. They are 9.5 percent of the 18,076 drug recall records in the file. Companion pieces cover Class I and Class II recalls.

Fewer Class III recalls than a decade ago

Each record in the file is one product, and one recall event can cover many products. The openFDA field reference⁷ defines the event ID as "a numerical designation assigned by FDA to a specific recall event used for tracking purposes." Counting both shows the same direction. Class III records peaked at 180 in 2017, and events peaked at 119 in 2016. Both have fallen by more than half since.

Source: GxRadar analysis of the openFDA drug enforcement file⁶; year is the Enforcement Report date. Events total 1,164.

Shares move around because the other classes do. In 2024, all drug recall records fell to 657, so 68 Class III records made up a larger slice than 89 had in 2023. In 2026, Class III is running ahead of 2025, with 44 events through Oct. 28 against 38 for all of last year. The full yearly series for every class is on GxRadar's recall charts.

Labels, impurity tests and potency lead the list

FDA describes each recall reason in free text. GxRadar sorts those descriptions into nine groups with a fixed set of keyword rules, the same ones used on our recall reasons page, so the categories are ours rather than FDA's. The right-hand column shows how much of each category ends up in Class III.

Source: GxRadar analysis of openFDA drug enforcement records, June 2012 to Oct. 28, 2026 (1,720 Class III records).

The pattern fits the regulation. When FDA scientists set a class, 21 CFR 7.41² tells them to weigh whether anyone has been hurt, who is likely to be exposed, how serious the hazard is and how likely it is to occur. A potency result that drifts a few points outside its limit, or a tablet that dissolves too slowly at a stability time point, often lands in Class III or Class II. Sterility problems almost never do. Of 9,273 sterility and contamination records in the file, only 145 were Class III. Of those 145, 98 describe foreign matter, a stray tablet in a bottle, a hair, or cross-contamination with another product, and only 18 mention sterility or microbes.

Potency is the category most likely to be judged low-hazard. Nearly four in 10 potency records are Class III. Dissolution and other specification failures are close to three in 10. Our explainers on out-of-specification results and dissolution testing describe the lab tests behind those recalls.

"Impurities" in Class III does not mean nitrosamines

One caveat applies to the impurity group. GxRadar's rules put nitrosamines, benzene and other impurities and degradants in one bucket. Among Class III records, not one reason mentions a nitrosamine. Every one of the 493 drug recall records in the file that mention a nitrosamine was classified as Class II.

The 380 Class III impurity records instead describe products that failed their impurity or degradation limits, usually during stability testing. Typical wording in 2025 and 2026 reads "Failed Impurities/Degradation Specifications," sometimes with a named impurity and the month of the stability test at which it went over. The nitrosamine story, which began with valsartan in 2018, is covered in our pieces on nitrosamine impurities and the valsartan recall.

What a Class III recall looked like in 2025 and 2026

Reading the 82 Class III recall events posted since January 2025 gives a sense of the range. Labeling cases include tablets imprinted with the wrong identification code, bottles with a missing or misprinted lot number or expiration date, one expiration date printed with an extra digit, and a label wrap that covered the barcode so it could not be scanned. A mispack case involved a carton whose stated size did not match the bottle inside.

Other entries are lab findings. Several describe subpotent results at a scheduled stability test. A run of 2026 records cites trace contamination of an active ingredient with a different active ingredient, linked to a problem at the ingredient supplier. One 2026 record describes a single tablet of a lower strength found in a bottle of a higher strength of the same drug.

A recall class is FDA's judgment about the hazard a product poses in general. It says nothing about any one person's situation. Questions about a specific lot belong with the dispensing pharmacist, and FDA's consumer guide to recalls¹² explains how recall notices identify affected products. Our guides on checking whether a medicine was recalled, pill imprint codes and where lot numbers sit on a package explain what to look for on a label.

How Class III recalls are run and closed

Class affects the plan. Under 21 CFR 7.42³, each recall strategy sets a depth (wholesale, retail, or consumer and user level), decides whether a public warning is needed, and picks an effectiveness-check level from A, meaning every consignee is contacted, down to E, meaning no checks. Public warnings, the rule says, are "reserved for urgent situations." The FDA Regulatory Procedures Manual⁹ sets out how the agency monitors those steps.

A recall ends when FDA decides "all reasonable efforts have been made" to remove or correct the product, according to 21 CFR 7.55⁴. Of the 1,720 Class III records, 1,525 are marked terminated, 21 completed and 174 ongoing. Fifty-one of this year's 54 are still open, as are most recent recalls in every class. More on that process is in How drug recalls end and recall depth and effectiveness checks.

New Class III entries appear in the weekly Enforcement Report⁸, which 21 CFR 7.50¹¹ requires FDA to publish with each recall listed by class, and FDA's drug recalls page¹⁰ lists the recall announcements that firms issue publicly. The next report after Oct. 28 will show whether 2026 passes last year's total of 61 Class III records; it needs eight more.