[ 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
Lidocaine Hydrochloride InjectionInjectionFresenius Kabi USA, LLCAnesthesiaAvailableCurrent2012-02-22
Morphine Sulfate InjectionInjectionFresenius Kabi USA, LLCAnalgesia/AddictionUnavailableCurrent2017-10-31
Carboplatin InjectionInjectionFresenius Kabi USA, LLCOncologyUnavailableCurrent2023-04-28
Lidocaine Hydrochloride InjectionInjectionFresenius Kabi USA, LLCAnesthesiaUnavailableCurrent2012-02-22
Rocuronium Bromide InjectionInjectionSandoz Inc.AnesthesiaAvailableCurrent2023-02-15
Lidocaine Hydrochloride InjectionInjectionFresenius Kabi USA, LLCAnesthesiaAvailableCurrent2012-02-22
Lidocaine Hydrochloride InjectionInjectionFresenius Kabi USA, LLCAnesthesiaUnavailableCurrent2012-02-22
Bupivacaine Hydrochloride InjectionInjectionFresenius Kabi USA, LLCAnesthesiaAvailableCurrent2018-02-20
Dextrose Monohydrate 5% InjectionInjectionB. Braun Medical Inc.Endocrinology/MetabolismAvailableCurrent2022-02-14
Methylphenidate Film, Extended ReleaseFilm, Extended ReleaseNoven Pharmaceuticals, Inc.PsychiatryAvailableCurrent2025-02-28
Bupivacaine Hydrochloride InjectionInjectionFresenius Kabi USA, LLCAnesthesiaAvailableCurrent2018-02-20
Hydromorphone Hydrochloride InjectionInjectionFresenius Kabi USA, LLCAnalgesia/AddictionUnavailableCurrent2017-10-31
Rocuronium Bromide InjectionInjectionFresenius Kabi USA, LLCAnesthesiaAvailableCurrent2023-02-15
Azacitidine InjectionInjectionFresenius Kabi USA, LLCOncologyAvailableCurrent2020-12-18
Morphine Sulfate InjectionInjectionFresenius Kabi USA, LLCAnalgesia/AddictionUnavailableCurrent2017-10-31
Amino Acid InjectionInjectionB. Braun Medical Inc.GastroenterologyAvailableCurrent2020-12-08
Lorazepam InjectionInjectionFresenius Kabi USA, LLCNeurologyAvailableCurrent2018-05-03
Methotrexate Sodium InjectionInjectionFresenius Kabi USA, LLCRheumatologyAvailableCurrent2023-03-13
Sterile Water IrrigantIrrigantB. Braun Medical Inc.GastroenterologyAvailableCurrent2023-04-28
Lidocaine Hydrochloride InjectionInjectionFresenius Kabi USA, LLCAnesthesiaAvailableCurrent2012-02-22
Ropivacaine Hydrochloride InjectionInjectionFresenius Kabi USA, LLCAnesthesiaUnavailableCurrent2018-03-23
Dextrose Monohydrate 10% InjectionInjectionB. Braun Medical Inc.Endocrinology/MetabolismAvailableCurrent2022-03-01
Midazolam Hydrochloride InjectionInjectionFresenius Kabi USA, LLCAnesthesiaUnavailableCurrent2020-04-02
Amino Acid InjectionInjectionB. Braun Medical Inc.GastroenterologyAvailableCurrent2020-12-08
Ropivacaine Hydrochloride InjectionInjectionFresenius Kabi USA, LLCAnesthesiaUnavailableCurrent2018-03-23
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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).