Top 10 Companies With the Most Current FDA Drug Shortage Listings: 2026
Fresenius Kabi USA, LLC leads this ranking, with 30 distinct current FDA drug shortage entries associated with its reported company name in the FDA CDER export retrieved October 12, 2026. Hikma Pharmaceuticals USA, Inc. follows with 28, and Hospira, Inc., a Pfizer Company with 26. The retrieval date is not an FDA-certified dataset-wide effective date; the latest update date among included records is October 6, 2026.
A three-way tie at tenth place means the top-ten cutoff, including ties, includes 12 reported company names. These counts describe associations with FDA shortage entries—not responsibility for a shortage, company quality, market share, or company-wide supply failure.
Table of contents
- Top-ten cutoff, including ties, at a glance
- What the counts measure
- How to interpret this list
- Current shortages, resolved shortages, and discontinuations
- Dates and limits of the snapshot
- Frequently asked questions
- Explore FDA shortage records in QOPE
- Sources
Top-ten cutoff, including ties, at a glance
The table counts each reported company and FDA entry-key pair once, even when an entry has multiple presentations. Rank ties are preserved; alphabetical order within ties is only for display.
| Rank | Company name as reported by FDA | Distinct current entries |
|---|---|---|
| 1 | Fresenius Kabi USA, LLC | 30 |
| 2 | Hikma Pharmaceuticals USA, Inc. | 28 |
| 3 | Hospira, Inc., a Pfizer Company | 26 |
| 4 | Baxter Healthcare | 16 |
| 5 | Eugia US LLC | 11 |
| 6 | Teva Pharmaceuticals USA, Inc. | 10 |
| 7 | Accord Healthcare Inc. | 7 |
| 7 | B. Braun Medical Inc. | 7 |
| 7 | Gland Pharma Limited | 7 |
| 10 | Amphastar Pharmaceuticals, Inc. | 6 |
| 10 | Mylan Institutional, a Viatris Company | 6 |
| 10 | Somerset Therapeutics, LLC | 6 |
These are the leading reported company names in the FDA CDER export retrieved October 12, 2026, not a ranking of corporate families. Names were retained as reported, without merging companies based on inferred ownership.
What the counts measure
The underlying FDA Center for Drug Evaluation and Research (CDER) drug-shortages export contained 1,580 presentation-level rows across three statuses: Current, Resolved, and To Be Discontinued. The ranking includes only the 1,141 rows marked Current. Those rows represent 69 distinct FDA shortage entries and 92 distinct reported company names. This population does not cover shortages tracked separately by other FDA centers, such as CBER's biological-product shortages.
The counting unit is one company name paired with one FDA entry key. A company listed across multiple presentations for the same entry—such as different strengths or package sizes—counts once for that entry. The resulting population contains 285 distinct company–entry pairs.
Within the included current population, company names, generic names, recovered FDA entry keys, presentations, availability information, update dates, and initial posting dates had no missing values. Blank shortage reasons were not imputed and do not affect company–entry counting.
The FDA export does not provide a separate numeric shortage identifier in the fields used here. Entry keys were matched to FDA’s current shortage-detail links using the AI value in each detail URL. All 69 distinct current generic-name entries in the export matched a current-entry link.
How to interpret this list
A company’s count indicates how many distinct current FDA entries are associated with its reported name. It is useful as a way to identify which names appear across more listed entries, but it does not show how many of that company’s products are affected overall, the extent of a shortage, or a company’s share of the market.
Nor does an association establish that a company caused a shortage or is responsible for a supply disruption. FDA describes potential shortage reasons that include manufacturing or quality requirements, regulatory delays, ingredient supply, shipping delays, increased demand, and discontinuation. In the included current records, the Reason for Shortage field was blank in 731 of 1,141 rows, so this ranking cannot explain the causes behind every listing.
Company names are not standardized or consolidated. For example, Hospira, Inc., a Pfizer Company remains its own reported label; this analysis does not merge it with Pfizer Inc. or infer corporate relationships. The same rule applies to all names in the table.
Current shortages, resolved shortages, and discontinuations
The ranking excludes resolved entries and discontinuations. In the export, 19 rows were marked Resolved and 420 were marked To Be Discontinued; neither category contributes to the counts.
These statuses describe different situations. FDA defines a current shortage in terms of U.S. supply not meeting current or projected demand. A resolved designation means FDA determines supply is no longer exceeded by demand or projected demand, but does not guarantee that every manufacturer or presentation is available. A discontinuation listing reflects information received about a permanent discontinuance; it is not itself a current shortage count.
The ranking included all rows marked Current, regardless of presentation-level availability wording. FDA notes that a presentation marked available does not by itself mean the shortage has been resolved.
Dates and limits of the snapshot
The export was retrieved October 12, 2026. The CSV does not publish a dataset-wide effective timestamp, so the retrieval date should not be read as a certified date on which every record was current. Among rows included in the ranking, Date of Update values ranged from May 1 through October 6, 2026. Initial posting dates ranged from January 1, 2012 through August 27, 2026.
These are dates recorded on included entries, not a statement that the dataset covers only that period. Older entries remain in scope if they were marked Current in the export.
Finally, an FDA shortage listing does not mean there is zero supply nationally, and it does not determine what is in stock at a particular pharmacy. FDA tracks shortages at the national level; local availability can differ.
Frequently asked questions
Does a higher count mean a company is more responsible for shortages?
No. The count measures how many distinct current FDA shortage entries are associated with a reported company name. It does not establish cause or responsibility.
Why does the list contain 12 companies if it is a top 10?
Three reported company names tie at rank 10, each with six entries. Including all companies at the top-ten cutoff produces 12 names. Competition ranking assigns the displayed ranks 1–7 and 10.
Are resolved shortages and discontinued drugs included?
No. Only rows marked Current were counted. Resolved and discontinuation records were excluded from this ranking.
Does a current listing mean my pharmacy has no supply?
No. FDA’s listing is a national measure and does not establish local pharmacy stock. Contact a pharmacist or healthcare provider about local availability and appropriate options.
Explore FDA shortage records in QOPE
Use QOPE’s Drug Shortages dataset to explore fields such as company, shortage status, presentation, availability, reason, and posting or update dates. To examine records associated with a ranked company, compare its reported name, generic names, statuses, and presentations, keeping the one-company–entry counting rule in mind. Check the record’s dates and status before using it to assess a particular medicine.
Sources
- FDA Drug Shortages, accessed October 12, 2026
- FDA Frequently Asked Questions about Drug Shortages