Mylan Institutional, A Viatris Company: FDA regulatory profile
Mylan Institutional, A Viatris Company appears in 6 indexed U.S. FDA records: 6 drug-shortage entries (from 15 openFDA source rows), naming 6 distinct products. Latest dated event: a shortage record dated 2026-08-20. Observations run 2019-02-08 to 2026-08-20 — 2750 days, 12 dated records across 6 calendar years, busiest 2026 with 6. Shortages: 6 current, averaging 2.5 package lines each across 13 FDA therapeutic categories, 10 strengths, 54 package NDCs and 5 brand names. 6 related firms and 8 adjacent shortage entries are linked below, each by a shared shortage entry, substance or therapeutic category. Every figure here is a count or a date computed from the indexed FDA datasets over a finite window: coverage-limited activity signals, never quality ratings or judgements about the firm. By year: 2026 (6), 2023 (1), 2022 (2), 2021 (1), 2020 (1), 2019 (1). Shortage entries include Dexamethasone Sodium Phosphate Injection (Current, since 2019-02-08, 4 lines), Dexmedetomidine Hydrochloride Injection (Current, since 2020-04-10, 3 lines), Etomidate Injection (Current, since 2022-10-05, 2 lines) and Remifentanil Hydrochloride Injection (Current, since 2022-06-28, 3 lines).
Regulatory snapshot
| Indexed records | 6 |
|---|---|
| Recall records | 0 |
| Shortage entries | 6 |
| Source rows filed | 15 |
| Approval records | 0 |
| Current shortages | 6 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 6 |
| Recall classifications | 0 |
| Recall statuses | 0 |
| First observed | 2019-02-08 |
| Latest observed | 2026-08-20 |
| Latest event type | shortage |
| Dated observations | 12 |
| Years covered | 6 |
| Span (days) | 2750 |
| Busiest year | 2026 (6 records) |
| Lines per entry (mean) | 2.5 |
| Therapeutic categories | 13 |
| Distinct strengths | 10 |
| Package NDCs | 54 |
| Brand names | 5 |
| Related firms / shortages | 6 / 8 |
Counts, not a rating. Coverage-limited activity signals over the ingested window — never reputational scores or judgements about the firm or its products.
Record breakdown
| Dimension | Value | Records | Share |
|---|---|---|---|
| Shortage status | Current | 6 | 100% |
| Therapeutic category | Anesthesia | 3 | 50% |
| Therapeutic category | Analgesia/Addiction | 1 | 17% |
| Therapeutic category | Anti-Infective | 1 | 17% |
| Therapeutic category | Dermatology | 1 | 17% |
| Therapeutic category | Endocrinology/Metabolism | 1 | 17% |
| Therapeutic category | Gastroenterology | 1 | 17% |
| Therapeutic category | Hematology | 1 | 17% |
| Therapeutic category | Neurology | 1 | 17% |
| Therapeutic category | Oncology | 1 | 17% |
| Therapeutic category | Ophthalmology | 1 | 17% |
| Therapeutic category | Other | 1 | 17% |
| Therapeutic category | Pulmonary/Allergy | 1 | 17% |
| Therapeutic category | Rheumatology | 1 | 17% |
Current shortages (6)
Reported by this firm and recorded by the FDA as active. Each links to its canonical entry.
| Shortage | Status | Since | Updated | Lines filed | Presentations | Strengths |
|---|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection | Current | 2019-02-08 | 2026-08-20 | 4 | 4 | 10 mg/1 mL, 4 mg/1 mL |
| Dexmedetomidine Hydrochloride Injection (Dexmedetomidine IN Dextrose, Precedex) | Current | 2020-04-10 | 2026-08-20 | 3 | 3 | 100 ug/1 mL, 200 ug/50 mL, 400 ug/100 mL |
| Etomidate Injection (Amidate) | Current | 2022-10-05 | 2026-08-20 | 2 | 2 | 2 mg/1 mL |
| Remifentanil Hydrochloride Injection (Ultiva) | Current | 2022-06-28 | 2026-08-20 | 3 | 3 | 1 mg/1 mL, 2 mg, 5 mg |
| Rifampin Injection (Rifadin) | Current | 2021-02-17 | 2026-08-20 | 1 | 1 | 600 mg |
| Rocuronium Bromide Injection | Current | 2023-02-15 | 2026-08-20 | 2 | 2 | 10 mg/1 mL |
Package lines filed (15)
The openFDA shortage lines this firm filed, with the agency's own availability text.
| Shortage | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection | Dexamethasone Sodium Phosphate, Injection, 4 mg/1 mL (NDC 67457-421-30) | 4 mg/1 mL | 67457-421-30 | Current | Available | 2026-08-20 |
| Dexamethasone Sodium Phosphate Injection | Dexamethasone Sodium Phosphate, Injection, 4 mg/1 mL (NDC 67457-423-12) | 4 mg/1 mL | 67457-423-12 | Current | Available | 2026-08-20 |
| Dexamethasone Sodium Phosphate Injection | Dexamethasone Sodium Phosphate, Injection, 10 mg/1 mL (NDC 67457-420-10) | 10 mg/1 mL | 67457-420-10 | Current | Available | 2026-08-20 |
| Dexamethasone Sodium Phosphate Injection | Dexamethasone Sodium Phosphate, Injection, 4 mg/1 mL (NDC 67457-422-54) | 4 mg/1 mL | 67457-422-54 | Current | Available | 2026-08-20 |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10) | 400 ug/100 mL | 67457-925-10 | Current | Available | 2026-08-20 |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02) | 100 ug/1 mL | 67457-251-02 | Current | Available | 2026-08-20 |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50) | 200 ug/50 mL | 67457-924-50 | Current | Available | 2026-08-20 |
| Etomidate Injection | Etomidate, Injection, 2 mg/1 mL (NDC 67457-902-10) | 2 mg/1 mL | 67457-902-10 | Current | Available | 2026-08-20 |
| Etomidate Injection | Etomidate, Injection, 2 mg/1 mL (NDC 67457-903-20) | 2 mg/1 mL | 67457-903-20 | Current | Available | 2026-08-20 |
| Remifentanil Hydrochloride Injection | Ultiva, Injection, 1 mg/1 mL (NDC 72078-034-01) | 1 mg/1 mL | 72078-034-01 | Current | Available | 2026-08-20 |
| Remifentanil Hydrochloride Injection | Ultiva, Injection, 2 mg (NDC 72078-035-02) | 2 mg | 72078-035-02 | Current | Available | 2026-08-20 |
| Remifentanil Hydrochloride Injection | Ultiva, Injection, 5 mg (NDC 72078-036-05) | 5 mg | 72078-036-05 | Current | Available | 2026-08-20 |
| Rifampin Injection | Rifampin, Injection, 600 mg (NDC 67457-445-60) | 600 mg | 67457-445-60 | Current | Unavailable | 2026-08-20 |
| Rocuronium Bromide Injection | Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 67457-228-10) | 10 mg/1 mL | 67457-228-10 | Current | Available | 2026-08-20 |
| Rocuronium Bromide Injection | Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 67457-228-05) | 10 mg/1 mL | 67457-228-05 | Current | Available | 2026-08-20 |
Products and drugs named (6)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection | shortage | 4 | 2026-08-20 |
| Dexmedetomidine Hydrochloride Injection | shortage | 3 | 2026-08-20 |
| Etomidate Injection | shortage | 2 | 2026-08-20 |
| Remifentanil Hydrochloride Injection | shortage | 3 | 2026-08-20 |
| Rifampin Injection | shortage | 1 | 2026-08-20 |
| Rocuronium Bromide Injection | shortage | 2 | 2026-08-20 |
Indexed activity by year
Counts within the ingested window across 12 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 0 | 6 | 0 | 6 |
| 2023 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 1 | 0 | 1 |
Related manufacturers
Linked by a co-reported shortage entry or a shortage of the same active substance — never inferred from name or sector.
| Firm | Relation | Records | Recalls | Shortages | Latest |
|---|---|---|---|---|---|
| Accord Healthcare, Inc. | co-reports the same shortage | 7 | 1 | 6 | 2026-08-20 |
| Azurity Pharmaceuticals, Inc | co-reports the same shortage | 1 | 0 | 1 | 2026-08-20 |
| Baxter Healthcare | co-reports the same shortage | 14 | 0 | 14 | 2026-08-20 |
| Epic Pharma, LLC | reports a shortage of the same substance | 2 | 0 | 2 | 2026-08-20 |
| HQ Specialty Pharma | co-reports the same shortage | 1 | 0 | 1 | 2026-08-20 |
| Lupin Pharmaceuticals Inc. | reports a shortage of the same substance | 5 | 3 | 2 | 2026-08-18 |
Related shortages in this firm's areas
Not reported by this firm, but sharing a substance identifier or therapeutic category with one that is.
| Shortage | Status | Relation | Since | Updated | Presentations | Firms |
|---|---|---|---|---|---|---|
| Dextrose Monohydrate 10% Injection | Current | same therapeutic category | 2022-03-01 | 2026-08-17 | 4 | 2 |
| Dextrose Monohydrate 5% Injection | Current | same therapeutic category | 2022-02-14 | 2026-08-17 | 14 | 2 |
| Dextrose Monohydrate 70% Injection | Current | same therapeutic category | 2024-10-11 | 2026-08-17 | 1 | 1 |
| Dextrose Monohydrate 50% Injection | Current | same therapeutic category | 2022-01-13 | 2026-08-18 | 1 | 1 |
| Sodium Bicarbonate Injection | Current | same therapeutic category | 2017-03-01 | 2026-08-18 | 2 | 2 |
| Methotrexate Sodium Injection | Current | same therapeutic category | 2023-03-13 | 2026-08-17 | 2 | 2 |
| Sterile Water Irrigant | Current | same therapeutic category | 2023-04-28 | 2026-08-17 | 2 | 2 |
| Cromolyn Sodium Concentrate | Current | same therapeutic category | 2023-11-03 | 2026-08-20 | 1 | 1 |
Source limitations
Built from the 6 ingested FDA records for this firm (0 recall, 6 shortage, 0 approval) — not its full regulatory history. The window is finite and can lag the live record, and alternate spellings of a firm name may sit under separate profiles. Confirm details at the linked official source. Regulatory information only: no safety assessment, no recommendation.
How to read these records
Where to go next
Source & provenance
- Official source
- https://open.fda.gov/apis/drug/enforcement/
- Source dataset
- openFDA (enforcement + shortages + Drugs@FDA)
- Publication date
- Not available
- Ingested
- 2026-08-22
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.