What FDA's Class I drug recall records show

On Oct. 28, 2026, FDA's weekly Enforcement Report listed two argatroban injection products, a hospital blood thinner, as Class I recalls. The reason given was particulate matter "identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution." The same week brought a Class I recall of a glutathione injection for microbial contamination.

Class I is the label FDA reserves for products where, in the agency's recall definitions¹, there is "a reasonable probability" that use or exposure "will cause serious adverse health consequences or death." It is also the smallest of the three classes. An openFDA count by classification² puts Class I at 1,753 of 18,076 drug recall records since June 2012, or 9.7 percent.

GxRadar pulled those 1,753 records from the openFDA drug enforcement data², which run through Oct. 28, 2026, and sorted them by year, recall event and reason. Most of them involve contamination or products that were never legitimate medicines to begin with. Ordinary tablets that fail a lab test rarely land there. For the full recall file, see Drug recalls by the numbers and our recall charts.

One event made 2019 look like a crisis

An openFDA query of Class I records by report date² shows 511 in 2019. No other year tops 152. But a separate count by event² shows that 465 of those records belong to a single recall event: homeopathic liquid products, some labeled for teething children, recalled for microbial contamination and posted on March 20, 2019.

Each record is one product, so a firm that recalls its whole product line generates hundreds of rows at once. Counting distinct events gives a steadier picture. From 2013 through 2026, Class I events ranged from 29 to 75 a year.

Source: GxRadar analysis of the openFDA drug enforcement file; year is the Enforcement Report date. Event counts sum to 659.

The 2024 share looks high for a different reason. Total recall records fell that year to 657, the lowest full-year count in the data, so 106 Class I records made up a larger slice.

Contamination and hidden drugs fill most of the list

FDA describes each recall in free text. GxRadar grouped those descriptions with a fixed set of keyword rules, the same ones used across our recall pages, so the categories below are ours and carry the usual errors of a keyword sort. Lead found in a product, for example, falls under contamination, and a methanol finding can land in either contamination or impurities depending on the wording.

Events take the category of their first record. Shares are rounded.

Two categories account for seven in 10 Class I events. Contamination covers sterile products that may not be sterile, particles in injections, and microbes in products that were never meant to be sterile. The undeclared ingredient group is mostly products sold as dietary supplements that FDA testing found to contain prescription drugs. An openFDA search for Class I records whose reason contains the word "undeclared"² returns 313. GxRadar found 195 Class I records, in 98 events, naming sildenafil or tadalafil, the active ingredients in erectile dysfunction drugs that also appear on our sildenafil and tadalafil pages. FDA tracks many of these products in its health fraud product database³.

Quality failures of the kind most people picture are rare here. Dissolution failures, the classic tablet problem, produced nine Class I records in 14 years, and failed specifications another six. Those problems show up in large numbers in Class II, as our piece on common reasons for drug recalls describes.

The recurring themes inside the categories

Searching the reason text for specific words shows which problems recur. These counts overlap, since one reason can mention several things.

Source: GxRadar keyword search of openFDA Class I drug recall records, June 2012 to Oct. 28, 2026.

Methanol is the pandemic signature, as GxRadar's account of the methanol hand sanitizer recalls describes. The 53 records citing it fall between 2020 and 2024, 27 of them in 2021, and 50 of the 53 describe hand sanitizer. An openFDA search for Class I records mentioning methanol² confirms the 53. FDA kept a public list of hand sanitizers consumers should not use⁴, with entries noting products that "contains methanol" and recall dates running into 2024. Benzene peaked the same year, with 34 Class I records in 2021.

Particles in injectable products are the steadiest theme. They appear in 131 separate Class I events, with at least two in every year of the data and 13 so far in 2026. Descriptions of injections, infusions, vials or syringes appear in 385 Class I records from 236 events, roughly a third of all Class I events. Label mix-ups, where a package holds a different drug or strength than the label says, add another 48 events.

Almost all of these recalls start with the company. Every one of the 1,753 Class I records lists the recall as "Voluntary: Firm initiated." FDA's consumer guide to recalls⁵ notes that recalls "may be initiated voluntarily by a company, or at the request of the FDA," and the openFDA documentation² adds that a company sometimes recalls a product "after FDA raises concerns." Our explainers on how drug recalls work and FDA inspections and warning letters cover that sequence.

The last 90 days

From July 30 to Oct. 28, 2026, FDA posted 212 drug recall records. Nineteen were Class I, from 17 events. Thirteen cited particles in an injection or IV solution. FDA's text identified them as stainless steel in cyclophosphamide vials and in a 70 percent dextrose bag, fiberglass in a sodium chloride bag, glass in papaverine, epinephrine and an injectable arthritis biologic, and mixed plastics and metal in an imaging contrast agent and in argatroban. Particles were also reported in cefazolin, lactated Ringer's solution and a second sodium chloride product.

Three more records were glutathione injections recalled for microbial contamination or failed bacterial endotoxin tests. The remaining three were a thyroid tablet found to be superpotent, capsules found to contain undeclared dexamethasone and cyproheptadine, and a morphine syringe package that held a syringe of hydromorphone instead.

Class assignments can lag a recall by weeks or months, because FDA's Enforcement Report page⁶ explains that classification usually follows once the firm has supplied the information needed to judge the risk. Recalls still awaiting a class are posted as "not yet classified," and one such drug record was waiting as of Oct. 28. New Class I entries appear on the GxRadar feed as each weekly report is published, and our guide to reading a recall notice explains the lot and code fields that tell a pharmacist whether a given package is affected.