[ FDA DRUG SHORTAGES TRACKER ]

A drug shortage is a quality failure with a body count.

Live FDA drug shortage data (openFDA), grouped by status, availability, and therapeutic area. The FDA’s own root-cause analysis puts manufacturing and quality problems at the centre of the shortage crisis — which is why SPEQ treats the shortage list as a quality-system signal, not just a supply-chain one.

1,000
Active shortages tracked
789
Current
205
To be discontinued
196
Flagged unavailable
20% flagged unavailable · latest update 2026-07-27 · source: openFDA drug/shortages
NEW SHORTAGES POSTED · MONTHLY

By initial FDA posting date. openFDA lists active shortages, so older cohorts thin as entries resolve.

ACTIVE SHORTAGES BY THERAPEUTIC CATEGORY · TOP 10
WHY THIS SITS UNDER QUALITY, NOT LOGISTICS

The FDA’s 2019 report Drug Shortages: Root Causes and Potential Solutions found the dominant drivers are not scarcity of raw materials but a lack of incentives to produce, and manufacturing/quality problems that force production to stop. Mature quality systems — the difference a QMM assessment measures — are what keep a line running.

The economics of quality →FDA QMM framework →
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1,166 matching shortages
DrugCompanyTherapeutic areaAvailabilityStatusPosted
Travoprost Ophthalmic SolutionOphthalmic SolutionMylan Pharmaceuticals Inc., a Viatris CompanyOphthalmology—To Be Discontinued2026-07-07
Atropine Sulfate InjectionInjectionAmerican Regent, Inc.AnesthesiaAvailableCurrent2012-01-01
Dexmedetomidine Hydrochloride InjectionInjectionJiangsu Hengrui Pharmaceuticals Co., Ltd.AnesthesiaAvailableCurrent2020-04-10
Dexmedetomidine Hydrochloride InjectionInjectionJiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.)AnesthesiaAvailableCurrent2020-04-10
Atropine Sulfate InjectionInjectionAmerican Regent, Inc.AnesthesiaAvailableCurrent2012-01-01
Travoprost Ophthalmic SolutionOphthalmic SolutionMylan Pharmaceuticals Inc., a Viatris CompanyOphthalmology—To Be Discontinued2026-07-07
Dexmedetomidine Hydrochloride InjectionInjectionJiangsu Hengrui Pharmaceuticals Co., Ltd.AnesthesiaAvailableCurrent2020-04-10
Bupivacaine Hydrochloride InjectionInjectionONESOURCE SPECIALTY PTE LTDAnesthesiaAvailableCurrent2018-02-20
Amino Acid InjectionInjectionOtsuka ICU Medical LLCGastroenterologyAvailableCurrent2020-12-08
Dextrose Monohydrate 10% InjectionInjectionOtsuka ICU Medical LLCEndocrinology/MetabolismAvailableCurrent2022-03-01
Amino Acid InjectionInjectionOtsuka ICU Medical LLCGastroenterologyUnavailableCurrent2020-12-08
Amino Acid InjectionInjectionOtsuka ICU Medical LLCGastroenterologyUnavailableCurrent2020-12-08
Amino Acid InjectionInjectionOtsuka ICU Medical LLCGastroenterologyAvailableCurrent2020-12-08
Sterile Water IrrigantIrrigantOtsuka ICU Medical LLCGastroenterologyUnavailableCurrent2023-04-28
Methylphenidate Hydrochloride Tablet, Extended ReleaseTabletTrigen Laboratories, LLCPsychiatryLimitedCurrent2023-07-26
Dextrose Monohydrate 5% InjectionInjectionOtsuka ICU Medical LLCEndocrinology/MetabolismAvailableCurrent2022-02-14
Dextrose Monohydrate 70% InjectionInjectionOtsuka ICU Medical LLCEndocrinology/MetabolismAvailableCurrent2024-10-11
Bumetanide InjectionInjectionMSN Laboratories Private LimitedCardiovascularAvailableCurrent2017-12-13
Lisdexamfetamine Dimesylate Tablet, ChewableTablet, ChewableNovadoz Pharmaceuticals LLCPsychiatryAvailableCurrent2023-07-14
Lisdexamfetamine Dimesylate Tablet, ChewableTablet, ChewableNovadoz Pharmaceuticals LLCPsychiatryAvailableCurrent2023-07-14
Lisdexamfetamine Dimesylate Tablet, ChewableTablet, ChewableNovadoz Pharmaceuticals LLCPsychiatryAvailableCurrent2023-07-14
Bumetanide InjectionInjectionMSN Laboratories Private LimitedCardiovascularAvailableCurrent2017-12-13
Lisdexamfetamine Dimesylate Tablet, ChewableTablet, ChewableNovadoz Pharmaceuticals LLCPsychiatryAvailableCurrent2023-07-14
Lisdexamfetamine Dimesylate Tablet, ChewableTablet, ChewableNovadoz Pharmaceuticals LLCPsychiatryAvailableCurrent2023-07-14
Bumetanide InjectionInjectionMSN Laboratories Private LimitedCardiovascularAvailableCurrent2017-12-13
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Data: U.S. FDA openFDA drug/shortages API, which lists activeshortages (Current or To Be Discontinued) — it carries no per-record cause field, so SPEQ makes no root-cause claim on individual drugs; the quality framing above is cited FDA context. openFDA publishes shortage data for drugs only; SPEQ’s cross-industry coverage lives in the recall Explorer(drug, device & food).