The 2026 drug recall year so far

Through Oct. 28, FDA had posted 704 drug recall records in 2026, according to GxRadar's analysis of the openFDA drug enforcement data¹. That is more than in the same stretch of either of the two previous years: 609 records from January through Oct. 28, 2025, and 516 in the same window of 2024.

The rise came almost entirely in Class II, the middle tier. FDA assigns the class after a health hazard evaluation by its scientists under 21 CFR 7.41¹⁰. Class I, the category FDA reserves for products with "a reasonable probability" of serious harm or death under 21 CFR 7.3⁴, has 38 records so far this year. That is the lowest count for the period in the three years compared here, and below the 49 recorded in all of 2025.

This piece sets out where 2026 stands through the last Enforcement Report in our data, what kinds of problems drove the count, and how the last 90 days compare. The numbers count records, and each record is one product. One recall event can produce dozens of records, which is why GxRadar also counts events where it matters. For the longer history, see Drug recalls by the numbers.

2026 against the same weeks of 2024 and 2025

Source: GxRadar analysis of openFDA drug enforcement records¹ by Enforcement Report date. The 2026 total includes one record FDA had not yet classified when the data were pulled. Event counts are distinct recall event IDs.

For the full calendar years, the totals were 657 records in 2024 (106 Class I, 483 Class II, 68 Class III) and 765 in 2025 (49 Class I, 655 Class II, 61 Class III). The year-to-date figures are on GxRadar's recall page, and the definitions of each class are on FDA's recall background page⁶.

Records and events both rose. Counting distinct recall events, which the openFDA field reference² describes as FDA's tracking number for "a specific recall event," 2026 reached 297 by Oct. 28, against 269 a year earlier. The full-year 2025 total was 327 events.

Class I tells a different story from the total. In 2024, 101 Class I records had posted by late October. In 2026 there were 38, and they came from 34 distinct events, so few were large multi-product recalls.

Contamination and manufacturing problems drove the count

FDA gives each recall a free-text reason. GxRadar sorts those reasons into groups using fixed keyword rules, the same ones used on our recall reasons page, so the groupings are ours rather than FDA's.

Source: GxRadar analysis of openFDA drug enforcement records. Shares are of each year's records in the window.

Sterility and contamination records rose to 303, or 43 percent of the year's total, the highest share of the three years. The group covers lack of sterility assurance, microbial contamination and particulate or foreign matter. It also accounts for 28 of the 38 Class I records. Our explainer on sterility assurance and recalls covers what those reasons mean in a plant.

A few large events add weight. The biggest 2026 event, posted Jan. 21, produced 27 Class II records citing CGMP deviations, described as "insanitary conditions including rodent exposure/activity" at a distribution center. An event posted Feb. 18 produced 25 records for "potential presence of metal particulate matter," and one posted June 10 produced 23 records for small metallic particles in chewable tablets. FDA's Enforcement Report³ carries each record with its product and lot details.

Potency problems doubled, from 31 records in the 2025 window to 64. Most were Class II.

Nitrosamine recalls fell back

Impurity recalls moved the other way. The group fell from 121 records in the 2025 window to 48 in 2026. Records whose reason mentions a nitrosamine dropped from 104 in all of 2025 to 23 so far in 2026, after 39 in 2024. Every one of them, in all three years, was classified Class II. The background is in our piece on nitrosamine impurities.

Labeling errors also declined, to 31 records from 82 in the 2024 window. Records for undeclared or unapproved ingredients, a group that includes products found to contain hidden drug ingredients, fell to seven.

Month by month

The pace picked up as the year went on. The first quarter brought 160 records, the second 221 and the third 247. October had 76 through the 28th. The busiest single month was July, at 111, and the quietest was February, at 46.

Source: GxRadar analysis of openFDA drug enforcement records by Enforcement Report date.

Monthly counts swing with the size of individual events, so a single multi-product recall can make a month look busy. FDA publishes the report weekly, as required by 21 CFR 7.50⁵, which directs the agency to list "each new recall according to its classification, whether it was Food and Drug Administration-requested or firm-initiated."

The last 90 days

In the 90 days before Nov. 3, the data show 206 recall records, 19 of them Class I. Sixteen of those 19 Class I records cite sterility, contamination or particulate matter, and the group accounts for 96 of the 206 records overall. CGMP deviations account for another 42. The most recent Class I entries include injectable products recalled for particulate matter, and FDA's drug recalls page⁷ posts the public announcements firms issue for some of them.

Almost all of this year's records are still open: 701 of 704 are marked ongoing. That is normal for recent recalls, which stay open until FDA finds that "all reasonable efforts have been made" to remove or correct the product, the test in 21 CFR 7.55¹¹. The steps between are set out in Chapter 7 of FDA's Regulatory Procedures Manual¹². Readers checking a specific product can start with our guide on how to check whether a medicine was recalled and the GxRadar live feed. Questions about a particular lot belong with the dispensing pharmacist.

FDA's consumer guide to recalls⁸ notes that recalls are generally initiated by a company or at FDA's request, and the agency's recalls and safety alerts page⁹ collects the public warnings. With 704 records through Oct. 28, 2026 needs 62 more to pass 2025's full-year total of 765. After Oct. 28 last year, FDA posted 156 more.