[ 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
852
Current
147
To be discontinued
212
Flagged unavailable
21% flagged unavailable · latest update 2026-07-30 · 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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1,178 matching shortages
DrugCompanyTherapeutic areaAvailabilityStatusPosted
Adalimumab-afzb InjectionInjectionPfizer Inc.Rheumatology—To Be Discontinued2025-10-09
Omeprazole Delayed Release CapsuleSandoz Inc.Gastroenterology—To Be Discontinued2025-10-09
Omeprazole Delayed Release CapsuleSandoz Inc.Gastroenterology—To Be Discontinued2025-10-09
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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).