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 |
|---|---|---|---|---|---|
| Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Available | Current | 2016-10-14 |
| Dextrose Monohydrate 10% InjectionInjection | Fresenius Kabi USA, LLC | Endocrinology/Metabolism | Available | Current | 2022-03-01 |
| Bupivacaine Hydrochloride, Epinephrine Bitartrate InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Available | Current | 2018-02-20 |
| Methylphenidate Film, Extended ReleaseFilm, Extended Release | Noven Pharmaceuticals, Inc. | Psychiatry | Available | Current | 2025-02-28 |
| Ropivacaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Unavailable | Current | 2018-03-23 |
| Ropivacaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Unavailable | Current | 2018-03-23 |
| Ropivacaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Available | Current | 2018-03-23 |
| Dextrose Monohydrate 70% InjectionInjection | B. Braun Medical Inc. | Endocrinology/Metabolism | Available | Current | 2024-10-11 |
| Dextrose Monohydrate 5% InjectionInjection | B. Braun Medical Inc. | Endocrinology/Metabolism | Available | Current | 2022-02-14 |
| Dextrose Monohydrate 5% InjectionInjection | Fresenius Kabi USA, LLC | Endocrinology/Metabolism | Unavailable | Current | 2022-02-14 |
| Dexamethasone Sodium Phosphate InjectionInjection | Fresenius Kabi USA, LLC | Dermatology | Available | Current | 2019-02-08 |
| Lidocaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Unavailable | Current | 2012-02-22 |
| Fentanyl Citrate InjectionInjection | Fresenius Kabi USA, LLC | Analgesia/Addiction | Available | Current | 2012-01-01 |
| Ropivacaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Unavailable | Current | 2018-03-23 |
| Lidocaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Available | Current | 2012-02-22 |
| Dexamethasone Sodium Phosphate InjectionInjection | Fresenius Kabi USA, LLC | Dermatology | Unavailable | Current | 2019-02-08 |
| Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Available | Current | 2016-10-14 |
| Ifosfamide InjectionInjection | Fresenius Kabi USA, LLC | Oncology | Unavailable | Current | 2026-06-12 |
| Ropivacaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Available | Current | 2018-03-23 |
| Ropivacaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Unavailable | Current | 2018-03-23 |
| Lidocaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Unavailable | Current | 2012-02-22 |
| Dexmedetomidine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Unavailable | Current | 2020-04-10 |
| Conivaptan Hydrochloride InjectionInjection | Cumberland Pharmaceuticals Inc. | Cardiovascular | Unavailable | Current | 2022-03-14 |
| Ropivacaine Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Anesthesia | Available | Current | 2018-03-23 |
| Remifentanil Hydrochloride InjectionInjection | Fresenius Kabi USA, LLC | Analgesia/Addiction | Available | Current | 2022-06-28 |
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).