Ondansetron recalls

The FDA has published 9 recalls involving Ondansetron since 2013. The latest was reported on 7 Jan 2026. Most were for manufacturing (cgmp) deviations. Hospira has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls9since 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 8 89%Class III 1 11%

Why ondansetron is recalled

Companies

Hospira222%
Fresenius Kabi USA222%
Dr. Reddy's Laboratories111%
Teva North America111%
Mckesson Medical-Surgical Inc. Corporate Office111%
Baxter Healthcare111%
Glenmark Pharmaceuticals Inc., U111%

Brands

Ondansetron556%
Ondansetron Hydrochloride222%

By year

2026111%
2023111%
2022111%
2019111%
2016222%
2014111%
2013222%

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

9 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
13 Dec 2023Drug	CLASS II	Ondansetron Injection, USP, 4 mg/ (2 mg/mL) per vial recalledOndansetron Hydrochloride	Baxter Healthcare	Other	Nationwide
15 Jun 2022Drug	CLASS II	Ondansetron HCL, Tab 8 mg filmcoated recalledOndansetron Hydrochloride	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
19 Jun 2019Drug	CLASS III	Ondansetron Injection, USP, 40 mg / vial recalled by Fresenius Kabi USAOndansetron	Fresenius Kabi USA	Potency & Assay	Nationwide
14 Sep 2016Drug	CLASS II	Ondansetron Injection USP 40 mg/ (2 mg/mL) recalled	Teva North America	Manufacturing (CGMP) Deviations	Nationwide
18 May 2016Drug	CLASS II	Ondansetron Tablets USP, 4 mg recalled by Dr. Reddy's Laboratories	Dr. Reddy's Laboratories	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

Should you stop taking Ondansetron?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.