Par Health Usa, LLC: FDA regulatory profile
Par Health Usa, LLC appears in 3 indexed U.S. FDA records: 1 recall record and 2 drug-shortage entries (from 4 openFDA source rows), naming 3 distinct products. Latest dated event: a shortage record dated 2026-08-20. Observations run 2020-04-10 to 2026-08-20 — 2323 days, 5 dated records across 3 calendar years, busiest 2026 with 3. Recalls: 1 Class II (100%); 1 ongoing by lifecycle status, reported 2026-06-24; 1 with an FDA recall number, 1 with an initiation date, across 1 state, grouped into 1 FDA recall event. Shortages: 2 current, averaging 2 package lines each across 2 FDA therapeutic categories, 3 strengths, 27 package NDCs and 3 brand names. 6 related firms and 6 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.
Regulatory snapshot
| Indexed records | 3 |
|---|---|
| Recall records | 1 |
| Shortage entries | 2 |
| Source rows filed | 4 |
| Approval records | 0 |
| Current shortages | 2 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 3 |
| Recall classifications | Class II: 1 |
| Recall statuses | Ongoing: 1 |
| First observed | 2020-04-10 |
| Latest observed | 2026-08-20 |
| Latest event type | shortage |
| Dated observations | 5 |
| Years covered | 3 |
| Span (days) | 2323 |
| Busiest year | 2026 (3 records) |
| Lines per entry (mean) | 2 |
| Therapeutic categories | 2 |
| Distinct strengths | 3 |
| Package NDCs | 27 |
| Brand names | 3 |
| Recall states | 1 |
| With recall number | 1 of 1 |
| FDA recall events | 1 |
| Related firms / shortages | 6 / 6 |
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 |
|---|---|---|---|
| Recall classification | Class II | 1 | 100% |
| Recall status | Ongoing | 1 | 100% |
| Shortage status | Current | 2 | 100% |
| Therapeutic category | Anesthesia | 1 | 50% |
| Therapeutic category | Rheumatology | 1 | 50% |
Current shortages (2)
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 |
|---|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride Injection (Dexmedetomidine IN Dextrose, Precedex) | Current | 2020-04-10 | 2026-08-20 | 3 | 3 | 100 ug/1 mL, 4 ug/1 mL |
| Methylprednisolone Acetate Injection (Depo-medrol) | Current | 2021-12-15 | 2026-08-18 | 1 | 1 | 80 mg/1 mL |
Package lines filed (4)
The openFDA shortage lines this firm filed, with the agency's own availability text.
| Shortage | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25) | 100 ug/1 mL | 42023-146-25 | Current | Available | 2026-08-18 |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20) | 4 ug/1 mL | 42023-186-20 | Current | Unavailable | 2026-08-18 |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10) | 4 ug/1 mL | 42023-187-10 | Current | Unavailable | 2026-08-18 |
| Methylprednisolone Acetate Injection | Methylprednisolone Acetate, Injection, 80 mg/1 mL (NDC 42023-240-01) | 80 mg/1 mL | 42023-240-01 | Current | Unavailable | 2026-08-18 |
Recall history (1)
Every enforcement report attributed to this firm, newest first. Classification is the FDA's severity tier, status its lifecycle position — neither is a safety statement.
| Product (as published) | Recall number | Classification | Status | Reported | Initiated |
|---|---|---|---|---|---|
| Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx O | D-0596-2026 | Class II | Ongoing | 2026-06-24 | 2026-06-12 |
Browse the wider classification index: Class II recalls.
Products and drugs named (3)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vi | recall | 1 | 2026-06-24 |
| Dexmedetomidine Hydrochloride Injection | shortage | 3 | 2026-08-20 |
| Methylprednisolone Acetate Injection | shortage | 1 | 2026-08-18 |
Indexed activity by year
Counts within the ingested window across 5 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 1 | 2 | 0 | 3 |
| 2021 | 0 | 1 | 0 | 1 |
| 2020 | 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 |
| HQ Specialty Pharma | co-reports the same shortage | 1 | 0 | 1 | 2026-08-20 |
| Mylan Institutional, A Viatris Company | co-reports the same shortage | 6 | 0 | 6 | 2026-08-20 |
| Sagent Pharmaceuticals | co-reports the same shortage | 6 | 1 | 5 | 2026-08-21 |
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 |
|---|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection | Current | same therapeutic category | 2019-02-08 | 2026-08-20 | 4 | 1 |
| Bupivacaine Hydrochloride Injection | Current | same therapeutic category | 2018-02-20 | 2026-08-18 | 1 | 1 |
| Lidocaine Hydrochloride Injection | Current | same therapeutic category | 2012-02-22 | 2026-08-18 | 2 | 2 |
| Midazolam Hydrochloride Injection | Current | same therapeutic category | 2020-04-02 | 2026-08-18 | 4 | 2 |
| Ropivacaine Hydrochloride Injection | Current | same therapeutic category | 2018-03-27 | 2026-08-18 | 6 | 1 |
| Methotrexate Sodium Injection | Current | same therapeutic category | 2023-03-13 | 2026-08-17 | 2 | 2 |
Source limitations
Built from the 3 ingested FDA records for this firm (1 recall, 2 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.