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

DimensionValueRecordsShare
Shortage statusCurrent6100%
Therapeutic categoryPediatric467%
Therapeutic categoryAnesthesia233%
Therapeutic categoryEndocrinology/Metabolism233%
Therapeutic categoryGastroenterology233%
Therapeutic categoryNeurology233%
Therapeutic categoryAnalgesia/Addiction117%
Therapeutic categoryCardiovascular117%

Current shortages (6)

Reported by this firm and recorded by the FDA as active. Each links to its canonical entry.

ShortageStatusSinceUpdatedLines filedPresentationsStrengths
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.

ShortagePresentationStrengthPackage NDCStatusAvailability (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 / drugRecord typeLinesDate
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.

YearRecallsShortage observationsApprovalsTotal
20260606
20220101
20180202
20170101
20120202

Related manufacturers

Linked by a co-reported shortage entry or a shortage of the same active substance — never inferred from name or sector.

FirmRelationRecordsRecallsShortagesLatest
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.

ShortageStatusRelationSinceUpdatedPresentationsFirms
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.

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.