Ondansetron recalls
The FDA has published 20 recalls involving Ondansetron since 2012. The latest was reported on 7 Jan 2026. Most were for sterility. RXQ Compounding 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 recalls 20 since 2012
Last 12 months 2 reported
Class I 0 0% of total
Ongoing 2 latest 7 Jan 2026
Recalls per month, last 24 months click a bar for that month Severity split
0 0%19 95%1 5%
Why ondansetron is recalled
Ongoing ondansetron recalls 2 active
All ondansetron recalls, newest first 20 total Reported Class Recall Company Reason Where 7 Jan 2026 Drug CLASS II Ondansetron Orally Disintegrating Tablets, USP, 4mg recalled Ondansetron Glenmark Pharmaceuticals Inc., USA Packaging Defects Nationwide 24 Dec 2025 Drug CLASS II Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled Preferred Pharmaceuticals Packaging Defects CA 13 Dec 2023 Drug CLASS II Ondansetron Injection, USP, 4 mg/ (2 mg/mL) per vial recalled Ondansetron Hydrochloride Baxter Healthcare Other Nationwide 22 Feb 2023 Drug CLASS II Ondansetron 8MG IN NS, antimetic recalled by Sentara Infusion Services Sentara Infusion Services Sterility Nationwide 15 Jun 2022 Drug CLASS II Ondansetron HCL, Tab 8 mg filmcoated recalled Ondansetron Hydrochloride Mckesson Medical-Surgical Inc. Corporate Office Manufacturing (CGMP) Deviations Nationwide 1 Jun 2022 Drug CLASS II Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose vial recalled Olympia Compounding Pharmacy Sterility Nationwide 21 Aug 2019 Drug CLASS II Ondansetron 8 MG / Ns Ivpb recalled by Infusion Options Infusion Options Sterility NY 14 Aug 2019 Drug CLASS II Ondansetron 2 MG/ML Injection Solution (Npf) per vial recalled RXQ Compounding Sterility Nationwide 14 Aug 2019 Drug CLASS II Ondansetron 2 MG/ML Injection Solution (Pfv) per vial recalled RXQ Compounding Sterility Nationwide 19 Jun 2019 Drug CLASS III Ondansetron Injection, USP, 40 mg / vial recalled by Fresenius Kabi USA Ondansetron Fresenius Kabi USA Potency & Assay Nationwide 16 May 2018 Drug CLASS II Ondansetron 8 mg tablet recalled by Kroger Specialty Pharmacy Kroger Specialty Pharmacy Other 5 states 14 Sep 2016 Drug CLASS II Ondansetron Injection USP 40 mg/ (2 mg/mL) recalled Teva North America Manufacturing (CGMP) Deviations Nationwide 20 Jul 2016 Drug CLASS II Ondansetron 2mg/mL fill in a syringe recalled Pharmakon Pharmaceuticals Sterility Nationwide 18 May 2016 Drug CLASS II Ondansetron Tablets USP, 4 mg recalled by Dr. Reddy's Laboratories Dr. Reddy's Laboratories Potency & Assay Nationwide 3 Feb 2016 Drug CLASS II Ondansetron HCL 8mg recalled by Sentara Enterprises Sentara Enterprises Sterility NC, VA 3 Feb 2016 Drug CLASS II Ondansetron 2 mg/mL, injectable recalled by Pharmakon Pharmaceuticals Pharmakon Pharmaceuticals Potency & Assay Nationwide 17 Dec 2014 Drug CLASS II Ondansetron Injection, USP, 4 mg/ (2 mg/mL) recalled Ondansetron Fresenius Kabi USA Particulate Matter Nationwide 27 Nov 2013 Drug CLASS II Ondansetron Injection, USP, 4 mg/ (2 mg/mL) Single-dose Vial recalled Ondansetron Hospira Foreign Material Nationwide 14 Aug 2013 Drug CLASS II Ondansetron Injection, USP, 4mg/, (2mg/ml) single-dose Fliptop Vial recalled Ondansetron Hospira Particulate Matter Nationwide 22 Aug 2012 Drug CLASS II Ondansetron HCL, Mdv 2mg/ML (40mg/ Injectable recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility 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.