Amphastar Pharmaceuticals, Inc.: FDA regulatory profile
Amphastar Pharmaceuticals, Inc. appears in 6 indexed U.S. FDA records: 6 drug-shortage entries (from 6 openFDA source rows), naming 6 distinct products. Latest dated event: a shortage record dated 2026-08-18. Observations run 2012-01-01 to 2026-08-18 — 5343 days, 12 dated records across 5 calendar years, busiest 2026 with 6. Shortages: 6 current, averaging 1 package lines each across 7 FDA therapeutic categories, 6 strengths, 25 package NDCs and 2 brand names. 5 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), 2022 (1), 2018 (2), 2017 (1), 2012 (2). Shortage entries include Atropine Sulfate Injection (Current, since 2012-01-01, 1 lines), Dextrose Monohydrate 50% Injection (Current, since 2022-01-13, 1 lines), Lidocaine Hydrochloride Injection (Current, since 2012-02-22, 1 lines) and Lorazepam Injection (Current, since 2018-05-03, 1 lines).
Regulatory snapshot
| Indexed records | 6 |
|---|---|
| Recall records | 0 |
| Shortage entries | 6 |
| Source rows filed | 6 |
| Approval records | 0 |
| Current shortages | 6 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 6 |
| Recall classifications | 0 |
| Recall statuses | 0 |
| First observed | 2012-01-01 |
| Latest observed | 2026-08-18 |
| Latest event type | shortage |
| Dated observations | 12 |
| Years covered | 5 |
| Span (days) | 5343 |
| Busiest year | 2026 (6 records) |
| Lines per entry (mean) | 1 |
| Therapeutic categories | 7 |
| Distinct strengths | 6 |
| Package NDCs | 25 |
| Brand names | 2 |
| Related firms / shortages | 5 / 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 | Pediatric | 4 | 67% |
| Therapeutic category | Anesthesia | 2 | 33% |
| Therapeutic category | Endocrinology/Metabolism | 2 | 33% |
| Therapeutic category | Gastroenterology | 2 | 33% |
| Therapeutic category | Neurology | 2 | 33% |
| Therapeutic category | Analgesia/Addiction | 1 | 17% |
| Therapeutic category | Cardiovascular | 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 |
|---|---|---|---|---|---|---|
| Atropine Sulfate Injection | Current | 2012-01-01 | 2026-08-18 | 1 | 1 | .1 mg/1 mL |
| Dextrose Monohydrate 50% Injection | Current | 2022-01-13 | 2026-08-18 | 1 | 1 | 25 g/50 mL |
| Lidocaine Hydrochloride Injection (Lidocaine Hydrochloride And Dextrose) | Current | 2012-02-22 | 2026-08-18 | 1 | 1 | 20 mg/1 mL |
| Lorazepam Injection (Ativan) | Current | 2018-05-03 | 2026-08-18 | 1 | 1 | 2 mg/1 mL |
| Morphine Sulfate Injection | Current | 2018-12-06 | 2026-08-18 | 1 | 1 | 1 mg/1 mL |
| Sodium Bicarbonate Injection | Current | 2017-03-01 | 2026-08-18 | 1 | 1 | 84 mg/1 mL |
Package lines filed (6)
The openFDA shortage lines this firm filed, with the agency's own availability text.
| Shortage | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Atropine Sulfate Injection | Atropine Sulfate, Injection, .1 mg/1 mL (NDC 76329-3340-1) | .1 mg/1 mL | 76329-3340-1 | Current | Available | 2026-08-18 |
| Dextrose Monohydrate 50% Injection | Dextrose Monohydrate 50%, Injection, 25 g/50 mL (NDC 76329-3302-1) | 25 g/50 mL | 76329-3302-1 | Current | Available | 2026-08-18 |
| Lidocaine Hydrochloride Injection | Lidocaine Hydrochloride, Injection, 20 mg/1 mL (NDC 76329-3390-1) | 20 mg/1 mL | 76329-3390-1 | Current | Limited Availability | 2026-08-18 |
| Lorazepam Injection | Lorazepam, Injection, 2 mg/1 mL (NDC 76329-8261-1) | 2 mg/1 mL | 76329-8261-1 | Current | Available | 2026-08-18 |
| Morphine Sulfate Injection | Morphine Sulfate, Injection, 1 mg/1 mL (NDC 76329-1912-1) | 1 mg/1 mL | 76329-1912-1 | Current | Available | 2026-08-18 |
| Sodium Bicarbonate Injection | Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 76329-3352-1) | 84 mg/1 mL | 76329-3352-1 | Current | Limited Availability | 2026-08-18 |
Products and drugs named (6)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Atropine Sulfate Injection | shortage | 1 | 2026-08-18 |
| Dextrose Monohydrate 50% Injection | shortage | 1 | 2026-08-18 |
| Lidocaine Hydrochloride Injection | shortage | 1 | 2026-08-18 |
| Lorazepam Injection | shortage | 1 | 2026-08-18 |
| Morphine Sulfate Injection | shortage | 1 | 2026-08-18 |
| Sodium Bicarbonate Injection | shortage | 1 | 2026-08-18 |
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 |
| 2022 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 2 | 0 | 2 |
| 2017 | 0 | 1 | 0 | 1 |
| 2012 | 0 | 2 | 0 | 2 |
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 |
|---|---|---|---|---|---|
| Baxter Healthcare | co-reports the same shortage; reports a shortage of the same substance | 14 | 0 | 14 | 2026-08-20 |
| Accord Healthcare, Inc. | co-reports the same shortage | 7 | 1 | 6 | 2026-08-20 |
| American Regent, Inc. | co-reports the same shortage | 2 | 1 | 1 | 2026-08-18 |
| Long Grove Pharmaceuticals LLC | co-reports the same shortage | 1 | 0 | 1 | 2026-08-18 |
| Otsuka Icu Medical LLC | reports a shortage of the same substance | 5 | 0 | 5 | 2026-08-17 |
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 |
| Dexamethasone Sodium Phosphate Injection | Current | same therapeutic category | 2019-02-08 | 2026-08-20 | 4 | 1 |
| Midazolam Hydrochloride Injection | Current | same therapeutic category | 2020-04-02 | 2026-08-18 | 4 | 2 |
| Clonazepam Tablet | Current | same therapeutic category | 2023-03-10 | 2026-08-17 | 6 | 3 |
| Dobutamine Hydrochloride Injection | Current | same therapeutic category | 2017-11-06 | 2026-08-17 | 1 | 1 |
| Sterile Water Irrigant | Current | same therapeutic category | 2023-04-28 | 2026-08-17 | 2 | 2 |
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.