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.
By initial FDA posting date. openFDA lists active shortages, so older cohorts thin as entries resolve.
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.
| Drug | Company | Therapeutic area | Availability | Status | Posted |
|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride InjectionInjection | Par Health, USA LLC | Anesthesia | Unavailable | Current | 2020-04-10 |
| Lisdexamfetamine Dimesylate CapsuleCapsule | Apotex Corp. | Psychiatry | Unavailable | Current | 2023-11-01 |
| Sodium Bicarbonate InjectionInjection | Amphastar Pharmaceuticals, Inc. | Endocrinology/Metabolism | Limited | Current | 2017-03-01 |
| Lisdexamfetamine Dimesylate CapsuleCapsule | Alvogen | Psychiatry | Available | Current | 2023-07-14 |
| Lisdexamfetamine Dimesylate CapsuleCapsule | Alvogen | Psychiatry | Available | Current | 2023-07-14 |
| Dextrose Monohydrate 50% InjectionInjection | Amphastar Pharmaceuticals, Inc. | Endocrinology/Metabolism | Available | Current | 2022-01-13 |
| Rifampin CapsuleCapsule | Epic Pharma, LLC | Anti-Infective | Unavailable | Current | 2021-12-22 |
| Carboplatin InjectionInjection | Avyxa Pharma, LLC | Oncology | Available | Current | 2023-04-28 |
| Hydromorphone Hydrochloride InjectionInjection | Teva Pharmaceuticals USA, Inc. | Analgesia/Addiction | Available | Current | 2017-11-01 |
| Clonazepam TabletTablet | Teva Pharmaceuticals USA, Inc. | Neurology | Available | Current | 2023-03-10 |
| Lisdexamfetamine Dimesylate CapsuleCapsule | Elite Laboratories, Inc. | Psychiatry | Limited | Current | 2023-07-14 |
| Lisdexamfetamine Dimesylate CapsuleCapsule | Lannett Company, Inc. | Psychiatry | Available | Current | 2023-07-14 |
| Methylphenidate Hydrochloride Tablet, Extended ReleaseTablet | Teva Pharmaceuticals USA, Inc. | Psychiatry | Limited | Current | 2023-07-26 |
| Carboplatin InjectionInjection | Teyro Labs | Oncology | Unavailable | Current | 2023-04-28 |
| Clonazepam TabletTablet | Teva Pharmaceuticals USA, Inc. | Neurology | Limited | Current | 2023-03-10 |
| Methylphenidate Hydrochloride Tablet, Extended ReleaseTablet | Vertical Pharmaceuticals, LLC | Psychiatry | Available | Current | 2023-07-26 |
| Quinapril Hydrochloride TabletTablet | Chartwell Molecular Holdings LLC | Cardiovascular | Available | Current | 2023-01-19 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletTablet | Oryza Pharmaceuticals Inc. | Psychiatry | Unavailable | Current | 2022-10-12 |
| Dexmedetomidine Hydrochloride InjectionInjection | Azurity Pharmaceuticals, Inc | Anesthesia | Available | Current | 2020-04-10 |
| Lisdexamfetamine Dimesylate CapsuleCapsule | Lannett Company, Inc. | Psychiatry | Available | Current | 2023-07-14 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletTablet | Teva Pharmaceuticals USA, Inc. | Psychiatry | Available | Current | 2022-10-12 |
| Lisdexamfetamine Dimesylate CapsuleCapsule | Elite Laboratories, Inc. | Psychiatry | Limited | Current | 2023-07-14 |
| Clonazepam TabletTablet | Cheplapharm Arzneimittel GmbH | Neurology | Available | Current | 2023-03-10 |
| Quinapril Hydrochloride TabletTablet | Chartwell Molecular Holdings LLC | Cardiovascular | Available | Current | 2023-01-19 |
| Peginterferon alfa-2a InjectionInjection | pharmaand GmbH (pharma&) | Antiviral | Available | Current | 2025-01-24 |
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).