Ondansetron recalls

Ondansetron products have been recalled 5 times, most recently on 7 Jan 2026. The recalling company is usually Fresenius Kabi USA. The most common reason is particulate matter.

Total recalls5since 2013

Last 12 months1reported

Class I00% of total

Ongoing1latest 7 Jan 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 1Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 80%Class III 1 20%

Why ondansetron is recalled

Companies

Product types

Stomach & Acid Reflux Medication5100%

By year

2026120%
2019120%
2014120%
2013240%

Ongoing ondansetron recalls

1 active

Reported	Class	Recall	Company	Reason	Where
7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., U	Packaging Defects	Nationwide

All ondansetron recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., U	Packaging Defects	Nationwide
19 Jun 2019Drug	CLASS III	Ondansetron Injection, USP, 40 mg / vial recalled by Fresenius Kabi USAOndansetron	Fresenius Kabi USA	Potency & Assay	Nationwide
17 Dec 2014Drug	CLASS II	Ondansetron Injection, USP, 4 mg/ (2 mg/mL) recalledOndansetron	Fresenius Kabi USA	Particulate Matter	Nationwide
27 Nov 2013Drug	CLASS II	Ondansetron Injection, USP, 4 mg/ (2 mg/mL) Single-dose Vial recalledOndansetron	Hospira	Foreign Material	Nationwide
14 Aug 2013Drug	CLASS II	Ondansetron Injection, USP, 4mg/, (2mg/ml) single-dose Fliptop Vial recalledOndansetron	Hospira	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.