American Regent recalls

American Regent has 21 recalls on record with the FDA and USDA, the earliest in 2024 and the latest reported on 3 Sep 2026. 19 are still ongoing. 14 were reported in the last 12 months. The most frequent reason is particulate matter.

Total recalls21since 2024

Last 12 months14reported

Class I15% of total

Ongoing19latest 3 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 3 0Jan '25 0 0 0Apr 2 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 1 0 0Jul 12 1

Severity split

Class I 1 5%Class II 18 86%Class III 1 5%Other/pending 1

Why american regent is recalled

Product types

Injectable & IV Drugs2095%
Other15%

Brands

By year

20261467%
2025210%
2024524%

Ongoing american regent recalls

19 active

Reported	Class	Recall	Company	Reason	Where
3 Sep 2026Food	ANNOUNCED	Epinephrine Injection, USP 30 mg/ (1 mg/mL) multi dose vial recalledAmerican Regent, Inc.	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Tralement (trace elements injection 4*, USP) recalled by American RegentTralement	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Selenious Acid Injection, USP 12 mcg/ (6 mcg/, For intravenous use recalledSelenious Acid	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg/ 5 mg/mL) recalledNicardipine Hydrochloride	American Regent	Particulate Matter	Nationwide

All american regent recalls, newest first

21 total

Reported	Class	Recall	Company	Reason	Where
3 Sep 2026Food	ANNOUNCED	Epinephrine Injection, USP 30 mg/ (1 mg/mL) multi dose vial recalledAmerican Regent, Inc.	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Tralement (trace elements injection 4*, USP) recalled by American RegentTralement	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Selenious Acid Injection, USP 12 mcg/ (6 mcg/, For intravenous use recalledSelenious Acid	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg/ 5 mg/mL) recalledNicardipine Hydrochloride	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Nitroglycerin injection, USP, 50 mg/ (5 mg/mL) recalledNitroglycerin	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Atropine Sulfate injection, USP, 1 mg/mL recalled by American RegentAtropine Sulfate	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Acetylcysteine Solution, USP, 10% (100 mg/mL) recalledAcetylcysteine	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS I	Papaverine HCl Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride	American Regent	Particulate Matter	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.