Updated Nov 4, 2026FDA and CMS public dataIndependent · free · not health advice
GxRadar
Recalls & quality · Data story

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.

RECALL REASONS, 2012–2026

Not health advice. GxRadar is for general information only. Nothing here is medical, pharmacy, legal or financial advice. Do not start, stop or change any medicine based on this site. Talk to your pharmacist or prescriber about your own situation.

FDA posted 212 drug recall records between July 30 and Oct. 28, 2026. By GxRadar's sort of the product descriptions, 95 of them were for an injection, an infusion or an implant. Tablets came next with 37, then eye and ear products with 21. Of the 19 Class I records in that stretch, 17 were injectables.

That tilt toward products that go into a vein or muscle is not new. Across the whole openFDA recall file, which begins in June 2012, injectables account for about two in five recall records and more than one in four recall events. Tablets match them on events, for different reasons.

Which kinds of products get recalled sounds like a simple question. The federal data make it harder than it looks. FDA's recall file has a field for route of administration, but it is filled in for only one record in six. The rest have to be sorted by reading the product description. GxRadar did both, using the openFDA drug enforcement data1 through Oct. 28, 2026, and this piece explains what each method can and cannot show.

The route field covers a minority of records

openFDA attaches standardized fields, including route, brand and generic name and product type, to records it can match to FDA's drug listings. An openFDA search shows only 2,928 records with a route1, or 16.2 percent of the 18,076 in the file. The openFDA field documentation2 explains why: "Because the harmonization process requires an exact match, some drug products cannot be harmonized in this fashion." Some products "will have openfda sections, while others will never, if there was no match."

Compounded drugs, unapproved products and items sold as supplements often have no listing to match. Coverage has risen in recent years. Only 4.5 percent of records reported in 2015 carry a route, compared with 47.6 percent in 2025 and 55.0 percent so far in 2026.

Within the matched records, oral products lead. An openFDA count by route1 gives these totals.

Route (openFDA field)RecordsShare of 2,928 records with a route
Oral1,59354.4%
Intravenous52818.0%
Topical2508.5%
Intramuscular2016.9%
Ophthalmic1545.3%
Subcutaneous983.3%
Transdermal742.5%
Inhalation461.6%
Nasal401.4%

Source: openFDA drug enforcement API, June 2012 to Oct. 28, 2026. Shares add to more than 100 percent because 219 records list more than one route.

Split by product type, the same field shows 2,510 prescription records and 467 over-the-counter records1 among those matched. For Class I, the most serious tier, the route count1 reverses the order. Intravenous leads with 123 records, oral has 49 and intramuscular 24.

Sorting all 18,076 records by description

To cover the whole file, GxRadar read each product description for words that signal a dosage form, such as vial, syringe or infusion bag for injectables, and tablet or capsule for oral solids. Rules ran in a fixed order, so a description that mentions both an injection and a solution counts once, as an injection. Events are placed in the form of their first record.

Dosage form (GxRadar keyword sort)RecordsShare of recordsEventsShare of eventsClass I records
Injection, infusion or implant6,98438.6%1,29527.4%417
Tablet3,21817.8%1,35328.6%104
Liquids, oral or unspecified2,14011.8%4499.5%579
Skin products (creams, gels, patches, sanitizers)1,4177.8%50410.7%112
Capsule1,3067.2%54011.4%357
Eye or ear7133.9%1924.1%46
Bulk drug ingredient6453.6%661.4%10
Inhaled or nasal2991.7%861.8%28
Mouth and dental products1150.6%360.8%6
Other or unclear1,2396.9%2064.4%94
Total18,076100%4,727100%1,753

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

Records and events tell different stories. Injectables lead on records because compounding pharmacies, when they recall, often pull every sterile product they made, producing hundreds of rows at once. Tablets lead on events. The liquids row carries a large Class I count because of one 2019 event, a recall of homeopathic liquids for microbial contamination that alone produced 465 Class I records.

Keyword choices move the totals. A plain openFDA search for descriptions containing "injection" or "injectable"1 returns 4,007 records, against 6,984 in GxRadar's broader sort, which also catches vials, syringes, IV bags and pellets. A search for "tablets"1 finds 2,655, fewer than our 3,218 because many descriptions use the singular "tablet" or the abbreviation "tabs."

Each form fails in its own way

The opening phrase of FDA's recall reason shows how the problems differ by product type.

Dosage formEventsMost common opening reasons (events)
Injection, infusion or implant1,295Lack of assurance of sterility (327); presence of particulate matter (206); labeling (129)
Tablet1,353CGMP deviations (219); failed dissolution specifications (182); failed impurities/degradation specifications (136)
Capsule540Marketed without an approved NDA/ANDA (144); CGMP deviations (76); failed dissolution specifications (62)
Eye or ear192Lack of assurance of sterility (48); failed impurities/degradation specifications (21); defective container (16)

Source: GxRadar analysis of openFDA recall reasons by event.

Injected products bypass the body's outer defenses, which is why sterility and particles dominate their recall reasons. The same pattern runs through the Class I file, and sterile manufacturing is a recurring theme in sterile injectable shortages. Tablets mostly fail laboratory specifications. They dissolve too slowly or too fast, or they carry an impurity above its limit, as with the nitrosamine recalls that hit valsartan, losartan and metformin. Capsules have a third profile. Their leading reason, "marketed without an approved NDA/ANDA," usually describes a product sold as a supplement. About three in four of those capsule events name a hidden drug ingredient, such as sildenafil or sibutramine, in FDA's reason text.

Eye products sit closer to injectables than to pills. FDA's rule on ophthalmic products, 21 CFR 200.504, states that all preparations for use in the eye "should be sterile." FDA's FY2024 Report on the State of Pharmaceutical Quality3 noted that consumer complaints in fiscal 2023 ran high, "many associated with recalls of OTC eye drops and gel products," the period covered in our account of the 2023 eye drop recalls.

Recent years

From 2022 through October 2026, the order has been stable. Injectables and tablets traded the top spot, each with 75 to 102 events a year.

YearAll eventsInjectionTabletCapsuleSkin productsLiquidsEye or ear
2022331908336612412
2023291837825303119
2024311827943293621
20253278510252372115
2026 (to Oct. 28)297957534312319

Source: GxRadar analysis of openFDA drug enforcement records, by year of first report. Smaller categories are omitted.

Skin products had a spike of their own earlier in the decade, from the methanol hand sanitizer recalls. Hand sanitizer appears in 233 recall descriptions in the file, and 126 of those records were reported in 2020 and 2021. Of those 126, 72 name methanol in the recall reason. An openFDA search for "sanitizer"1 finds 219 of them by exact word.

Limits worth keeping in mind

None of these counts measures risk to any one patient. A recall record is a unit of paperwork. One lot of tablets and one compounded vial each count as one row, regardless of how many people received them, and the file has no figure for units sold. Products also differ in how closely they are tested and inspected, which shapes what gets caught.

For the broader file, see Drug recalls by the numbers, the reasons drugs get recalled and our recall charts. Anyone holding a product from a recalled lot can check it using our recall lookup guide and ask a pharmacist what to do next. As more recall records carry product codes, the route field should cover a growing share of new entries; it already reached 55 percent in 2026.

Sources and notes

  1. openFDA (2026). Drug recall enforcement reports API: documentation
    open.fda.gov/apis/drug/enforcement/
  2. openFDA (2026). openFDA fields and the limits of harmonization
    open.fda.gov/apis/openfda-fields/
  3. FDA (2025). Report on the State of Pharmaceutical Quality, FY2024
    www.fda.gov/media/193320/download
  4. Cornell LII (2026). 21 CFR 200.50, Ophthalmic preparations and dispensers
    www.law.cornell.edu/cfr/text/21/200.50

Superscript numbers in the text link to these sources. GxRadar data (NADAC histories, recall and shortage counts) come from CMS and FDA files described on the sources page. Researched and drafted with AI assistance and checked against the sources above. Information current as of Nov 3, 2026 and may change. Spot an error? It will be corrected once confirmed.

Not health advice. GxRadar is for general information only. Nothing here is medical, pharmacy, legal or financial advice. Do not start, stop or change any medicine based on this site. Talk to your pharmacist or prescriber about your own situation. Laws, prices and program rules described here can change; confirm current details with the official source.