Study Reveals the U.S. Pharmaceutical Firms with the Most FDA Recalls
Key takeaways:
- New study identifies the pharmaceutical firms with the most drug recalls in the U.S. from 2012-2024.
- Aidapak Services leads with 538 total recalls, while King Bio Inc. tops the list for most hazardous Class I recalls with 465 dangerous violations.
- The data reveals significant fluctuations in pharmaceutical recall activity over the past 13 years. 2019 stands out as the worst year on record.
The pharmaceutical industry has seen its share of quality control issues over the past decade, and this information is made public by the FDA on its website in the form of Warning letters and recalls.
Medidex, an AI-powered medical chatbot platform designed to streamline healthcare communication, decided to dig into more than a decade of FDA recall data. The company analyzed every pharmaceutical recall from 2012 through 2024, looking at both how often companies recalled products and how dangerous those recalls were.
The study examined FDA enforcement reports to spot patterns in recall activity. Companies were ranked not just by how many recalls they had, but also by how many fell into the FDA’s most serious ‘Class I’ category, reserved for products that could cause severe health problems or death.
Table 1: Top 10 Firms That Had The Most Drug Recalls
Firm Name
Total Recalls
Aidapak Services, LLC
538
Attix Pharmaceuticals
470
King Bio Inc.
465
The Compounding Pharmacy of America
383
Main Street Family Pharmacy, LLC
299
PharMEDium Services, LLC
289
Central Admixture Pharmacy Services, Inc.
273
Cardinal Health Inc.
208
Franck’s Lab Inc., d.b.a. Franck’s Compounding Lab
198
Teva Pharmaceuticals USA
196
The Compounding Connection
A closer look at the list reveals that many of these high-recall companies are compounding pharmacies rather than traditional pharmaceutical manufacturers. Companies like The Compounding Pharmacy of America (383 recalls), Main Street Family Pharmacy (299), and PharMEDium Services (289) all specialize in creating customized medications.
Table 2: Total Recalls Per Year For The Last 13 Years
Year
Total Recalls
2024
625
2023
1296
2022
1321
2021
1038
2020
1039
2019
2163
2018
1405
2017
1078
2016
1231
2015
2052
2014
1552
2013
1365
2012
459
Industry-Wide Recall Patterns
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
Firm name
Level 1
Level 2
Level 3
Total
King Bio Inc.
465
0
0
465
Main Street Family Pharmacy, LLC
299
0
0
299
PharMEDium Services, LLC
87
185
17
289
Reliable Rexall-A Compounding Pharmacy
70
0
0
70
Product Quest Manufacturing LLC
54
0
0
54
Central Admixture Pharmacy Services, Inc.
38
235
0
273
ICU Medical Inc
37
99
12
148
MICHIGAN HERBAL REMEDIES
36
0
0
36
Plastikon Healthcare LLC
25
0
0
25
Specialty Process Labs LLC
24
2
0
26
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
https://www.healthcarepackaging.com/industry-news/regulatory/article/22944644/study-reveals-the-us-pharmaceutical-firms-with-the-most-fda-recalls
