On Oct. 21, 2026, FDA revised its drug shortage entry for penicillin G benzathine injection, a long-acting antibiotic that the agency first posted as short on April 26, 2023. The smallest syringe, 600,000 units in 1 mL, was marked "Unavailable," with a next delivery of October 2027 and an estimated recovery of December 2027. The two larger syringes were listed as "Limited Availability." A version imported from Portugal under a temporary importation letter11 was listed as "Available."
That single entry uses nearly all of the database's vocabulary: status, availability, related information, shortage reason, therapeutic category and date first posted. Each term has a specific and sometimes narrow meaning, and several of them are supplied by manufacturers rather than decided by FDA.
GxRadar's shortage tracker is built from the same records. As of Nov. 3, 2026, FDA's list held 69 drugs in current shortage, 156 marked "to be discontinued" and 5 recently resolved. This guide goes through the fields one at a time, using FDA's own definitions, and then shows how the same data look in openFDA, the agency's public data service.
Where the list comes from
The list is a legal requirement. Under 21 U.S.C. 356e5, FDA must keep an up-to-date list of drugs it has determined to be in shortage, and each entry must give the drug's name and National Drug Code, the name of each manufacturer, the reason for the shortage chosen from seven statutory categories, and the estimated duration. The law was added by the Food and Drug Administration Safety and Innovation Act of 2012, covered in our piece on FDASIA and early notice.
FDA's shortage FAQ3 says the Drug Shortage Staff inside the Center for Drug Evaluation and Research updates the list daily, and that most of its information comes from manufacturers. The test is national. A drug is in shortage when supply across the country is not meeting current demand, or is not forecast to meet projected demand. FDA says reports of a medicine missing from one pharmacy are usually temporary distribution problems that clear when the pharmacy reorders.
It is also deliberately incomplete. In a 2024 explainer, FDA said CDER does not post every drug4 for which it receives a discontinuance or interruption notice, "to avoid hoarding of drugs and exacerbating supply concerns." A drug that is about to run short may not appear until FDA decides it actually is short.
The fields, one by one
Below, each field on a drug's page is paired with FDA's definition and the party that supplies the information. The definitions come from the FAQ, the database's own notes1 and openFDA's field reference7.
| Field | What it records, per FDA | Supplied by |
|---|---|---|
| Status | Currently in shortage, resolved, or discontinuation (a manufacturer's notice that it is permanently stopping a product) | FDA |
| Date first posted | The date the presentation was added to the public website | FDA |
| Therapeutic category | Labeled uses and populations where the drug is commonly used, such as Pediatric; a drug can carry several | FDA |
| Presentation | Drug name, dosage form, strength and NDC for one package | Manufacturer listing |
| Availability and estimated shortage duration | Available, Limited Availability or Unavailable | Manufacturer |
| Related information | Free text such as next delivery and estimated recovery dates, plus links to letters | Manufacturer |
| Shortage reason (per FDASIA) | One of the seven reasons listed in the statute | FDA, from manufacturer information |
| Update type and date | Whether a company's entry is new, revised or reverified, and when | FDA |
Status, and what "resolved" means
FDA's FAQ3 defines "currently in shortage" with the statutory language: demand or projected demand exceeds supply. A shortage is resolved "when FDA determines that supply is no longer exceeded by demand or projected demand." The database page adds a qualifier that matters to anyone holding a prescription. The market counts as covered when supply from at least one manufacturer can meet total demand, and the page says "some manufacturers may not have all presentations available."
Discontinuations are a separate list. They come from notices manufacturers must file under section 506C, and FDA says they are posted "for informational purposes only." Resolved entries stay on the site for six months and discontinued ones for a year, per the FAQ. The 156 discontinuation entries now outnumber current shortages more than two to one, a pattern we looked at in the 'to be discontinued' entries.
Reading a drug's page
A drug's detail page opens with its name, status, date first posted and therapeutic categories. Below that is one block per company, each stamped "Revised" or "Reverified" with a date, followed by a row for every presentation. Each row is one NDC, so a single drug can have dozens of rows. Our explainer on the NDC number covers how those codes are built.
Availability is the easiest column to misread. FDA's FAQ3 says the presentation details "are provided by the manufacturer and can change daily," and that "available" is "not an FDA determination that the shortage has been resolved." A drug can sit on the current list while most of its rows say available.
That is the normal state of the list. In openFDA's data updated Nov. 4, 2026, there were 1,153 presentation records under current shortages. Of those, 722 were marked Available, 274 Unavailable and 154 Limited Availability. The remaining three carried hand-typed variants, including "Limited Availalbility" and "Unvailable," a reminder that the field is entered as text.
Estimated recovery dates live in the related-information column, and 250 of the current records mention one. They move. A January 2026 manufacturer letter10 linked from the penicillin G benzathine entry projected recovery for the two larger syringes in the fourth quarter of 2026. By October, the database said September 2027.
Shortage reasons and therapeutic categories
By statute, FDA chooses from seven reasons, and the FAQ lists the same seven. The data do not stick to them. In openFDA's current records, 720 of 1,153 presentations have no reason at all, and the most common value among the rest is "Other," which is not one of the seven.
| Shortage reason (openFDA field shortage_reason) | Current presentation records |
|---|---|
| Other | 163 |
| Demand increase for the drug | 125 |
| Shortage of an active ingredient | 61 |
| Discontinuation of the manufacture of the drug | 46 |
| Delay in shipping of the drug | 21 |
| Requirements related to complying with good manufacturing practices | 14 |
| Regulatory delay | 2 |
| Shortage of an inactive ingredient component | 1 |
| No reason given | 720 |
| Total | 1,153 |
Source: GxRadar count of openFDA drug shortages data6, last updated Nov. 4, 2026. Counts are per presentation, which weights drugs with many package sizes more heavily. Our piece on shortage reasons in FDA data looks at the drug-level picture.
Therapeutic category is FDA's label for where a drug is used. The FAQ says it "does not indicate FDA approved status," and a drug may appear in more than one. Among the 69 current shortages, Pediatric is the most common tag, on 17 drugs, followed by Analgesia/Addiction on 11. GxRadar's breakdown by therapeutic area and dosage form shows that 71 percent of current shortages are injectables.
The same records in openFDA
openFDA publishes the shortage list as a free API, updated daily and covering records from 2012 on, according to its overview page6. Each record is one presentation. As of the Nov. 4 update there were 1,597 records: 1,153 current, 425 to be discontinued and 19 resolved. Those are package counts. FDA's drug-level list collapses them into the 69, 156 and 5 entries shown on GxRadar's tracker.
Field names map directly onto the web page: status, availability, related_info, shortage_reason, therapeutic_category, initial_posting_date, update_type and update_date, among others. The fields file8 gives a one-line definition for each. openFDA's how-to page9 explains the search syntax (a field name, a colon and a term) and notes that a single call returns at most 100 records. The service adds a standing caution: "Do not rely on openFDA to make decisions regarding medical care."
An entry's age is easy to compute from initial_posting_date. The median current shortage has been on the list for 1,710 days, about four and a half years, a figure we track in how long drug shortages last.
What the list cannot answer
The database says nothing about a particular pharmacy's shelf. FDA's FAQ3 suggests checking other pharmacies or asking a health care provider or pharmacist about alternatives, and it says "whether potential alternatives may be appropriate will depend on each patient." Those are questions for a pharmacist or prescriber, and our guides on what to ask during a shortage and what to ask about a back order list them. GxRadar's pharmacy finder lists nearby pharmacies by ZIP code.
It is also one list among several. Pharmacist-run trackers use a broader definition and usually count more shortages, which we explain in why FDA and ASHP counts differ.
A fuller annual picture comes from FDA's reports to Congress. The report for 202512 counted four new shortages that year and 93 ongoing at year's end. The law requires the next one, covering 2026, by March 31, 2027.
Sources and notes
- FDA (2026). Drug Shortages Database: Current and Resolved Drug Shortages and Discontinuations Reported to FDA
www.accessdata.fda.gov/scripts/drugshortages/default.cfm - FDA (2026). Drug Shortages Database entry: Penicillin G Benzathine Injection
www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Penicillin - FDA (2024). Frequently Asked Questions about Drug Shortages
www.fda.gov/drugs/drug-shortages/frequently-asked-questions-about-drug-shortages - FDA (2024). 7 Things to Know About Drug Shortage Management
www.fda.gov/drugs/news-events-human-drugs/7-things-know-about-drug-shortage-management - LII / US Code (2026). 21 U.S.C. 356e, Drug shortage list
www.law.cornell.edu/uscode/text/21/356e - openFDA (2026). Drug Shortages API overview
open.fda.gov/apis/drug/drugshortages/ - openFDA (2026). Drug Shortages searchable fields
open.fda.gov/apis/drug/drugshortages/searchable-fields/ - openFDA (2026). Drug Shortages field definitions (YAML)
open.fda.gov/fields/drugshortages.yaml - openFDA (2026). How to use the Drug Shortages endpoint
open.fda.gov/apis/drug/drugshortages/how-to-use-the-endpoint/ - FDA (2026). Availability update letter for penicillin G benzathine prefilled syringes, posted with the shortage entry
www.fda.gov/media/190713/download - FDA (2026). Dear Healthcare Provider letter on temporary importation of benzathine benzylpenicillin from Portugal
www.fda.gov/media/193578/download - FDA (2026). Report to Congress: Drug Shortages, CY 2025
www.fda.gov/media/193637/download
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 tools from the sources above and checked with automated and AI-assisted review; not individually reviewed by a pharmacist or physician. Information current as of Nov 3, 2026 and may change. Spot an error? Report it and it will be corrected once confirmed.
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Compounding during drug shortages, and the rules that switch on when a drug is listedDEA production quotas and drug shortagesThe penicillin G benzathine shortageThe reasons FDA gives for drug shortages, countedWhat FDA's shortage list shows in November 2026What to ask when the pharmacy has a back orderWhy FDA and ASHP count drug shortages differentlyNot 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.