Study Reveals the U.S. Pharmaceutical Firms with the Most FDA Recalls

The data reveals significant fluctuations in pharmaceutical recall activity over the past 13 years. 2019 stands out as the worst year on record with 2,163 recalls, followed closely by 2015 with 2,052. These peak years represent periods of heightened regulatory scrutiny and quality control failures across the industry.

The most recent complete year, 2023, saw 1,296 recalls – a substantial number that suggests ongoing quality challenges. Interestingly, 2024 shows only 625 recalls, though this likely reflects incomplete data since the study only captured recalls through May.

2012 recorded the fewest recalls at 459, which may indicate either better industry practices in earlier years or less comprehensive reporting mechanisms. The general trend shows recall activity has remained persistently high, rarely dropping below 1,000 annual recalls since 2013.

Table 3: Top 10 Firms With The Most Hazardous Recalls

FDA Recall Classifications:

• Class I: Products that could cause severe health problems or death
• Class II: Products that might cause temporary or serious health problems
• Class III: Products unlikely to cause health reactions but violate FDA regulations

When High Volume Meets High Risk

The most concerning finding emerges when comparing these two tables: several companies appear on both rankings, meaning they not only recall products frequently but also have recalls in the most dangerous categories.

King Bio Inc. presents a particularly striking profile. The company ranks third in total recalls (465) and first in hazardous recalls, with every single recall classified as Class I, the FDA's most serious category for products that could cause severe health problems or death.

Main Street Family Pharmacy shows a similar pattern, with all 299 of its recalls classified as Class I. This places the company fifth in total recalls and second in hazardous recalls, appearing prominently on both lists.

Different Risk Profiles Across Companies

PharMEDium Services presents a different picture despite its high total recall count. Of the company's 289 total recalls, 87 were Class I, 185 were Class II, and 17 were Class III. This means roughly 30% of PharMEDium's recalls involved the most serious safety risks.

Central Admixture Pharmacy Services shows yet another pattern, with 38 Class I recalls and 235 Class II recalls out of 273 total. Here, about 14% of recalls fell into the most dangerous category.

“Firms facing repeated quality failures need to conduct thorough reviews of their manufacturing processes and implement comprehensive corrective actions. The goal should be preventing problems before products leave the facility, not managing crises after they reach the market. Patient safety must always come first, and these numbers show there's still significant room for improvement across the industry,” says Simon Greenberg, Founder of Medidex.
 

Editor’s Note: While I did not fact check the AI tool’s work, I find it remarkable that AI has the power to scour through decades of data to come up with these findings.  
 

Methodology

Geographic Scope: Global
Time Frame: 2012 – 2024

Objective: To identify the most recalled pharmaceutical firms in the United States, both on a national scale and broken down by individual states.

Data Source: The primary data was collected from the U.S. Food and Drug Administration (FDA), specifically from its publicly available Recalls Database, which documents enforcement reports and recall events related to pharmaceutical products.

Data Collection & Processing: All recall records related to pharmaceutical products between 2012 and 2025 were extracted from the FDA's database. Year 2025 was excluded as the data was recorded only until May 31. Relevant fields included: company name, recall number, product description, recall classification (Class I, II, III), and recall initiation date.

Ranking Methodology:

• Firms were ranked based on the total number of recalls over the period
• Firms were ranked based on the total number of most hazardous recalls based on FDA levels
• Firms were ranked based on the total number of recalls in each year from 2012-2024
• Years were ranked based on the total number of recalls from all registered firms