[ 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
Remifentanil Hydrochloride InjectionInjectionHikma Pharmaceuticals USA, Inc.Analgesia/AddictionAvailableCurrent2022-06-28
Dexamethasone Sodium Phosphate InjectionInjectionHikma Pharmaceuticals USA, Inc.DermatologyAvailableCurrent2019-02-08
Sufentanil Citrate InjectionInjectionHikma Pharmaceuticals USA, Inc.Analgesia/AddictionUnavailableCurrent2022-05-03
Etomidate InjectionInjectionHikma Pharmaceuticals USA, Inc.AnesthesiaAvailableCurrent2022-10-05
Azacitidine InjectionInjectionHikma Pharmaceuticals USA, Inc.OncologyAvailableCurrent2020-12-18
Lidocaine Hydrochloride InjectionInjectionHikma Pharmaceuticals USA, Inc.AnesthesiaAvailableCurrent2018-06-13
Hydromorphone Hydrochloride InjectionInjectionHikma Pharmaceuticals USA, Inc.Analgesia/AddictionAvailableCurrent2017-11-03
Rocuronium Bromide InjectionInjectionHikma Pharmaceuticals USA, Inc.AnesthesiaAvailableCurrent2023-02-15
Dexamethasone Sodium Phosphate InjectionInjectionHikma Pharmaceuticals USA, Inc.DermatologyAvailableCurrent2019-02-08
Dexmedetomidine Hydrochloride InjectionInjectionHikma Pharmaceuticals USA, Inc.AnesthesiaUnavailableCurrent2020-04-10
Promethazine Hydrochloride InjectionInjectionHikma Pharmaceuticals USA, Inc.Analgesia/AddictionAvailableCurrent2023-11-21
Cefotaxime Sodium Powder, for SolutionPowder, For SolutionHikma Pharmaceuticals USA, Inc.Anti-InfectiveUnavailableCurrent2015-02-17
Cefotaxime Sodium Powder, for SolutionPowder, For SolutionHikma Pharmaceuticals USA, Inc.Anti-InfectiveUnavailableCurrent2015-02-17
Morphine Sulfate InjectionInjectionHikma Pharmaceuticals USA, Inc.Analgesia/AddictionAvailableCurrent2017-11-03
Bumetanide InjectionInjectionHikma Pharmaceuticals USA, Inc.CardiovascularAvailableCurrent2018-01-31
Sterile Water InjectionInjectionHikma Pharmaceuticals USA, Inc.OtherAvailableCurrent2021-11-23
Azacitidine InjectionInjectionBristol Myers Squibb Co.OncologyAvailableCurrent2020-12-18
Lorazepam InjectionInjectionHikma Pharmaceuticals USA, Inc.NeurologyLimitedCurrent2018-09-05
Meperidine Hydrochloride InjectionInjectionHikma Pharmaceuticals USA, Inc.Analgesia/AddictionUnavailableCurrent2025-05-30
Remifentanil Hydrochloride InjectionInjectionHikma Pharmaceuticals USA, Inc.Analgesia/AddictionAvailableCurrent2022-06-28
Lisdexamfetamine Dimesylate CapsuleCapsuleHikma Pharmaceuticals USA, Inc.PsychiatryLimitedCurrent2023-07-14
Ifosfamide InjectionInjectionHikma Pharmaceuticals USA, Inc.OncologyUnavailableCurrent2026-06-12
Morphine Sulfate InjectionInjectionHikma Pharmaceuticals USA, Inc.Analgesia/AddictionAvailableCurrent2017-11-03
Fentanyl Citrate InjectionInjectionHikma Pharmaceuticals USA, Inc.Analgesia/AddictionUnavailableCurrent2023-12-20
Penicillin G Benzathine InjectionInjectionLaboratorios AtralAnti-InfectiveAvailableCurrent2023-04-26
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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).