American Regent, Inc.: FDA regulatory profile

American Regent, Inc. appears in 2 indexed U.S. FDA records: 1 recall record and 1 drug-shortage entry (from 1 openFDA source row), naming 2 distinct products. Latest dated event: a shortage record dated 2026-08-18. Observations run 2012-01-01 to 2026-08-18 — 5343 days, 3 dated records across 2 calendar years, busiest 2026 with 2. Recalls: 1 Class III (100%); 1 ongoing by lifecycle status, reported 2026-05-06; 1 with an FDA recall number, 1 with an initiation date, across 1 state, grouped into 1 FDA recall event. Shortages: 1 current, averaging 1 package lines each across 3 FDA therapeutic categories, 1 strength, 14 package NDCs and 0 brand names. 2 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. This firm appears in 2 indexed records, which is below the threshold this site requires before treating a manufacturer page as a standalone regulatory profile (only 2 indexed record). The page is published so the record remains reachable and verifiable, and it links on to the underlying FDA records, but it is marked noindex and left out of the sitemap: a single appearance of a company name is not a regulatory history, and presenting it as one would overstate what the data supports. Should further records reference this firm in a later ingestion, the page becomes a full profile automatically.

Regulatory snapshot

Indexed records 2
Recall records 1
Shortage entries 1
Source rows filed 1
Approval records 0
Current shortages 1
Resolved shortages 0
Discontinued shortages 0
Unique products 2
Recall classifications Class III: 1
Recall statuses Ongoing: 1
First observed 2012-01-01
Latest observed 2026-08-18
Latest event type shortage
Dated observations 3
Years covered 2
Span (days) 5343
Busiest year 2026 (2 records)
Lines per entry (mean) 1
Therapeutic categories 3
Distinct strengths 1
Package NDCs 14
Brand names 0
Recall states 1
With recall number 1 of 1
FDA recall events 1
Related firms / shortages 2 / 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
Recall classificationClass III1100%
Recall statusOngoing1100%
Shortage statusCurrent1100%
Therapeutic categoryAnesthesia1100%
Therapeutic categoryNeurology1100%
Therapeutic categoryPediatric1100%

Current shortages (1)

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 .4 mg/1 mL

Package lines filed (1)

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, .4 mg/1 mL (NDC 0517-1004-25) .4 mg/1 mL 0517-1004-25 Current Available 2026-08-17

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 numberClassificationStatusReportedInitiated
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous D-0494-2026 Class III Ongoing 2026-05-06 2026-04-16

Browse the wider classification index: Class III recalls.

Products and drugs named (2)

De-duplicated by record entity, not raw source row.

Product / drugRecord typeLinesDate
Atropine Sulfate Injection shortage 1 2026-08-18
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose V recall 1 2026-05-06

Indexed activity by year

Counts within the ingested window across 3 dated records — not a trend.

YearRecallsShortage observationsApprovalsTotal
20261102
20120101

Related manufacturers

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

FirmRelationRecordsRecallsShortagesLatest
Accord Healthcare, Inc. co-reports the same shortage 7 1 6 2026-08-20
Amphastar Pharmaceuticals, Inc. co-reports the same shortage 6 0 6 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.

ShortageStatusRelationSinceUpdatedPresentationsFirms
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
Dexamethasone Sodium Phosphate Injection Current same therapeutic category 2019-02-08 2026-08-20 4 1
Etomidate Injection Current same therapeutic category 2022-10-05 2026-08-20 2 1
Rocuronium Bromide Injection Current same therapeutic category 2023-02-15 2026-08-20 6 4
Bupivacaine Hydrochloride Injection Current same therapeutic category 2018-02-20 2026-08-18 1 1
Ropivacaine Hydrochloride Injection Current same therapeutic category 2018-03-27 2026-08-18 6 1
Dextrose Monohydrate 10% Injection Current same therapeutic category 2022-03-01 2026-08-17 4 2

Source limitations

Built from the 2 ingested FDA records for this firm (1 recall, 1 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.