[ 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
Donepezil Hydrochloride; Memantine Hydrochloride Capsule, Extended ReleaseCapsule, Extended ReleaseAmneal PharmaceuticalsNeurologyTo Be Discontinued2026-06-15
Cefotaxime Sodium Powder, for SolutionPowder, For SolutionSteriMax, Inc.Anti-InfectiveAvailableCurrent2015-02-17
Cefotaxime Sodium Powder, for SolutionPowder, For SolutionSteriMax, Inc.Anti-InfectiveAvailableCurrent2015-02-17
Lorlatinib TabletTabletPfizer Inc.OncologyTo Be Discontinued2026-06-15
Ketorolac Tromethamine InjectionInjectionGland Pharma LimitedAnalgesia/AddictionAvailableCurrent2018-03-23
Ketorolac Tromethamine InjectionInjectionGland Pharma LimitedAnalgesia/AddictionAvailableCurrent2018-03-23
Ropivacaine Hydrochloride InjectionInjectionCaplin Steriles, Ltd.AnesthesiaLimitedCurrent2020-12-22
Ropivacaine Hydrochloride InjectionInjectionCaplin Steriles, Ltd.AnesthesiaAvailableCurrent2020-12-22
Ropivacaine Hydrochloride InjectionInjectionCaplin Steriles, Ltd.AnesthesiaAvailableCurrent2020-12-22
Liraglutide InjectionInjectionNovo Nordisk, Inc.Endocrinology/MetabolismAvailableCurrent2023-07-18
Liraglutide InjectionInjectionNovo Nordisk, Inc.Endocrinology/MetabolismAvailableCurrent2023-07-18
Liraglutide InjectionInjectionNovo Nordisk, Inc.Endocrinology/MetabolismLimitedCurrent2023-07-18
Liraglutide InjectionInjectionNovo Nordisk, Inc.Endocrinology/MetabolismAvailableCurrent2023-07-18
Azacitidine InjectionInjectionArmas Pharmaceuticals IncOncologyLimitedCurrent2020-12-18
Liraglutide InjectionInjectionNovo Nordisk, Inc.Endocrinology/MetabolismLimitedCurrent2023-07-18
Leflunomide TabletTabletSanofi-Aventis U.S. LLCRheumatologyTo Be Discontinued2026-06-08
Leflunomide TabletTabletSanofi-Aventis U.S. LLCRheumatologyTo Be Discontinued2026-06-08
Dacomitinib TabletTabletPfizer Inc.OncologyTo Be Discontinued2026-06-08
Leflunomide TabletTabletSanofi-Aventis U.S. LLCRheumatologyTo Be Discontinued2026-06-08
Leflunomide TabletTabletSanofi-Aventis U.S. LLCRheumatologyTo Be Discontinued2026-06-08
Dacomitinib TabletTabletPfizer Inc.OncologyTo Be Discontinued2026-06-08
Leflunomide TabletTabletSanofi-Aventis U.S. LLCRheumatologyTo Be Discontinued2026-06-08
Dacomitinib TabletTabletPfizer Inc.OncologyTo Be Discontinued2026-06-08
Dexmedetomidine Hydrochloride InjectionInjectionSlayback PharmaAnesthesiaTo Be Discontinued2026-06-05
Semaglutide TabletTabletNovo Nordisk, Inc.Endocrinology/MetabolismTo Be Discontinued2026-06-04
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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).