Recalls & quality
Recall records, manufacturing rules and the cases that changed them. 24 articles: 7 data story, 8 explainers, 2 how-to guides, 7 history.
Recall data
Drug recalls by the numbers
GxRadar counted all 18,076 FDA drug recall records from mid-2012 to October 2026 by year, class, event and reason. A handful of giant recall events explain most of the swings.
The reasons drugs get recalled, counted from FDA's own records
A GxRadar count of 18,076 FDA drug recall records since 2012 shows a handful of failure types, led by sterility, manufacturing lapses, impurities and pills that dissolve out of spec.
What FDA's Class I drug recall records show
FDA put 1,753 drug recall records in its most serious class between mid-2012 and October 2026. GxRadar sorted them by year, event and reason to see what actually ends up there.
What FDA's Class II drug recall records show
Four in five drug recall records are Class II. GxRadar counted 14,602 of them by year, event and reason, and found manufacturing lapses on the rise and a second nitrosamine wave in 2025.
Which kinds of drug products get recalled most
Injectables fill the most drug recall records and tablets the most recall events. GxRadar sorted 18,076 FDA records by dosage form and route, and explains why the federal route field covers only one in six.
How recalls work
How drug recalls end
FDA decides when a drug recall is over. GxRadar read the rules and timed 3,654 closed recalls: the median took 504 days, and terminations have slowed sharply since 2024.
How drug recalls work
Who starts a drug recall, how FDA sorts recalls into Class I, II and III, how far down the supply chain a recall reaches, and what 18,076 enforcement records since 2012 show.
How to check if your medicine was recalled
Where FDA publishes every drug recall it monitors, how to match a notice to your own bottle by NDC and lot number, and the questions that get a pharmacist to a quick answer.
How to read an FDA recall notice
A field-by-field reading of a real October 2026 Enforcement Report entry, what the recall classes and statuses mean, and how to check whether your own medicine comes from a recalled lot.
Manufacturing quality
CGMP and the rules behind drug manufacturing quality
What current good manufacturing practice requires under 21 CFR parts 210 and 211, how FDA inspectors check it, why data integrity matters, and what quality failures look like in FDA and openFDA recall data.
Data integrity in drug manufacturing
FDA's 2018 data integrity guidance, the ALCOA standard behind it, and how unreliable lab and production records turn into warning letters, import alerts and recalls.
Dissolution testing, the lab check behind many tablet recalls
How a dissolution test measures whether a pill releases its drug, how USP and FDA set the pass mark, and what 414 recall records citing dissolution show about which products fail.
FDA drug inspections by the numbers
FDA ran 1,248 drug quality inspections in fiscal 2025, and US plants drew the most serious grade more often than any region. Seven years of counts, outcomes by region, and what follows a bad result.
FDA inspections, Form 483s and warning letters
FDA ran 1,248 drug quality inspections in fiscal 2025 and judged 18 percent of them unacceptable. How plants are chosen, what a Form 483 is and is not, and how warning letters and import alerts follow.
How FDA import alerts stop drugs at the border
FDA can hold drug shipments at the border without testing them. How import alerts and their red, yellow and green lists work, how many drug alerts are active, and how plants get on and off them.
Case histories
Benzene in sprays, sanitizers and acne products, and the limits FDA set
Where benzene in some over-the-counter drugs came from, how FDA's 2 ppm and 20 mcg-a-day limits work, what its 2023 carbomer guidance asks, and what 100 recall records show.
How a carcinogen in blood pressure pills changed generic drug testing
Since 2018, nitrosamine impurities have produced nearly 500 federal recall records, pushed ranitidine off the US market and led FDA to set daily intake limits for impurities formed from the drug itself.
The 2008 heparin contamination
How a counterfeit ingredient called oversulfated chondroitin sulfate got into the US heparin supply, how FDA and CDC traced it, and what changed in oversight of drug ingredients afterward.
The 2020 metformin recalls and the NDMA found in extended-release tablets
How FDA testing found a probable carcinogen in some extended-release metformin in 2020, why the common immediate-release tablets were spared, and what 47 federal recall records show.
The 2023 eye drop recalls
How a drug-resistant bacterium in imported artificial tears sickened 81 people in 18 states, why FDA later warned against 26 store-label eye drops, and what changed for eye product makers.
The methanol hand sanitizer recalls of 2020 and 2021
How methanol got into hand sanitizer during the pandemic rush, why FDA put a whole country's sanitizer exports on import alert, and what 665 list entries and 89 recall records show.
The ranitidine withdrawal of 2020
How NDMA findings in ranitidine moved FDA from lot recalls in 2019 to a request in April 2020 that every maker pull the drug, and what the recall records and later research show.
The valsartan recall and what it did to prices
After FDA's July 2018 valsartan recalls, the national average cost of a 160 mg tablet rose from 9.5 cents to 37 cents in five months. Eight years later it is still above its pre-recall level.
The generic drug scandal of 1989
How bribes and falsified data inside FDA's generic drug office led to criminal convictions, a collapse in approvals, and the 1992 law that lets FDA bar people from the drug industry.