The reasons FDA gives for drug shortages, counted

On FDA's drug shortage list as it stood on Nov. 3, 2026, the most common reason attached to a current shortage was "Other." It sits beside 30 of the 69 drugs the agency lists as currently short, including heparin, morphine and hydromorphone injections, sodium bicarbonate, and the local anesthetics bupivacaine and ropivacaine. Seven more drugs carry no reason at all.

That is an odd result for a field Congress spelled out in law. When it passed the Food and Drug Administration Safety and Innovation Act in 2012, Congress told FDA to publish, for each drug on the list, "the reason for the shortage, as determined by the Secretary," chosen from seven categories now codified at 21 U.S.C. 356e³. "Other" is not one of them.

GxRadar counted the reasons on the list using FDA's drug shortage data as published through openFDA¹, then set them against what FDA's own researchers concluded in the agency's 2019 report on the root causes of shortages⁵. The two sources tell different stories. The list leans on demand and on an unlabeled catch-all. The 2019 analysis found that most shortages started with a manufacturing or quality problem. For background on the causes themselves, see Why drug shortages happen.

Seven categories in the statute, and one more in the data

Congress kept the list short. FDA is to pick from requirements related to good manufacturing practices, regulatory delay, shortage of an active ingredient, shortage of an inactive ingredient component, discontinuance of manufacture, delay in shipping, and demand increase, according to section 506E of the Food, Drug, and Cosmetic Act³.

FDA's data are recorded one presentation at a time, meaning a specific package with its own National Drug Code. The openFDA field reference² describes the reason field simply as the "Reason for shortage of the presentation." On Nov. 3, the current list covered 1,153 presentations. Of those, 747, or 65 percent, had the reason field blank.

Our guide to reading FDA's shortage database explains how those package-level entries roll up. To get one reason per drug, GxRadar took the most common stated reason among each drug's presentations. That simplifies things. Of the 63 current drugs with any stated reason, 41 carry two or more different reasons across their packages. Carboplatin injection, for example, lists four: demand increase, delay in shipping, discontinuation and "Other."

Source: GxRadar analysis of FDA drug shortage records via openFDA, as of Nov. 3, 2026. A drug's reason is the most common one among its current presentations; "Not stated" means none of its presentations gave a reason. Time on list runs from the first posting date. Percentages are rounded.

Demand leads the named reasons

Among the reasons that come from the statute, "Demand increase for the drug" is the most common by a wide margin, covering 15 drugs. Thirteen are injectables. The group includes lidocaine injection, first posted in February 2012, along with dexamethasone, midazolam, sterile water for injection and 5 percent dextrose. The newest is ifosfamide injection, a cancer drug added in June 2026.

A demand label on a shortage that has run for over a decade is hard to read at face value. The median drug in this group has been on the list for about 4.9 years. FDA's shortage FAQ⁷ notes that when one company has a problem or stops making a drug, "it can be difficult for the remaining firms to increase production quickly." In that situation the remaining makers see a jump in orders, and a demand label may describe that second stage rather than whatever started the shortage.

Reasons that point at the factory are the rarest. Only three current drugs carry the good manufacturing practice label: atropine sulfate injection, desmopressin nasal spray and riluzole oral suspension. Three more cite a shortage of active ingredient, and two of those are stimulant medicines whose ingredients fall under federal production quotas. One, flurazepam capsules, is listed for regulatory delay.

FDA's 2019 analysis pointed to quality problems

FDA's interagency task force looked at the question differently. Its economists took 163 drugs that went into shortage from 2013 through 2017 and sorted them by what set each shortage off. According to the report⁵, 62 percent went into shortage after supply disruptions "associated with manufacturing or product quality problems." Another 18 percent went short for unknown reasons, 12 percent after unanticipated demand increases, 5 percent after natural disasters and 3 percent after product discontinuations.

By the report's count, 101 of the 115 supply disruptions in the sample, or 88 percent, were tied to quality issues. The task force went on to name three root causes, all economic: low incentives to make less profitable drugs, a market that does not reward mature quality systems, and logistical and regulatory hurdles that slow recovery after a disruption, as summarized on FDA's report page⁶. Our explainer on CGMP covers the quality rules the second root cause refers to.

FDA repeats the point in plainer language today. "Manufacturing quality issues are the most common reason for drug shortages," the agency says in its drug shortage FAQ⁷.

An earlier federal analysis found the same pattern and the same measurement problem. A 2011 issue brief from HHS's Office of the Assistant Secretary for Planning and Evaluation reported that quality problems were linked to 54 percent of sterile injectable shortages. The ASPE brief⁸ also reproduced reasons tracked by the University of Utah drug information service, where "unknown" was the largest single category. That service's counts feed ASHP's shortage list, which is one reason FDA and ASHP counts differ.

Sources: GxRadar analysis of openFDA shortage data; FDA (2019), Drug Shortages: Root Causes and Potential Solutions; ASPE (2011), Economic Analysis of the Causes of Drug Shortages⁹. Definitions and periods differ, so the columns are not directly comparable; shipping delays (6 percent today) have no match in the other two.

Why the labels and the analysis diverge

List categories and the task force's categories measure different things. The task force traced each shortage back to its trigger using sales data and internal FDA records. The list records a reason per package, and it is kept current as conditions change, so a drug that went short after a plant problem years ago may now be labeled for demand, shipping delays or nothing at all.

The law also gives FDA room to say less. Under section 356e(c)³, the agency may hold back information if it decides disclosure "would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of drug products to patients)."

Manufacturers are the main source of what FDA knows. Since 2012, makers of certain prescription drugs have had to tell FDA about a permanent discontinuance or a manufacturing interruption likely to disrupt supply, generally six months ahead, under 21 U.S.C. 356c⁴ and the FDASIA early-notice rules. The 2020 CARES Act widened that duty to cover active ingredients and required the notice to include the reasons, as FDA explains on its CARES Act shortage page¹² (more in our piece on the CARES Act and shortage reporting). Those reasons go to FDA. They do not necessarily reach the public list in the same words.

What the "Other" group looks like

The 30 drugs labeled "Other" are mostly old hospital staples. Twenty-six are injectables. Two, fentanyl citrate injection and a lidocaine with epinephrine injection, trace back to postings in early 2012, and the median drug in the group has been listed for about 6.1 years. They include the cardiac drugs dobutamine and dopamine, the anesthesia drug dexmedetomidine, carboplatin and methotrexate for cancer care, and penicillin G benzathine.

That longevity is typical of the current list as a whole, where the median shortage was first posted 1,710 days ago, or about 4.7 years (see how long shortages last). Seventy-one percent of current shortages involve injectables, according to GxRadar's shortage tracker. The task force's 2013 to 2017 sample looked similar: 63 percent of its 163 drugs were sterile injectables and 67 percent had a generic version on the market, according to the 2019 report⁵.

For anyone trying to learn why a particular drug is short, the reason field is a starting point. The presentation-level records in the database linked from FDA's drug shortages page¹¹ sometimes carry notes on availability and expected recovery, and those notes are often more specific than the category.

New shortages, at least, have become rare. FDA's report to Congress for calendar year 2025¹⁰ counted four new shortages that year, down from a peak of 251 in 2011, and said the agency helped prevent 330. It also counted 93 ongoing shortages at the end of 2025. The report for 2026 will be the next place to see whether FDA describes the causes of the shortages it still carries.