CLASS III Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Ondansetron Injection, USP, 40 mg / vial recalled by Fresenius Kabi USA
Fresenius Kabi USA is recalling Ondansetron Injection, USP, 40 mg / vial, distributed nationwide in the US. The recall was initiated on 22 May 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1386-2019
- FDA event ID
- 82915
- Recalling firm
- Fresenius Kabi USA, Grand Island, NY
- Brand
- Ondansetron
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 May 2019
- FDA classified
- 14 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 22 May 2019 | Recall initiated by company | |
| 14 Jun 2019 | Classified by FDA | +23 days |
| 19 Jun 2019 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications.
Which lots are affected?
Lot #: 6018699, Exp. 12/2021
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 94| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Ondansetron recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled | Preferred Pharmaceuticals | Packaging Defects | CA |
| Drug | CLASS II | Ondansetron Injection, USP, 4 mg/ (2 mg/mL) per vial recalledOndansetron Hydrochloride | Baxter Healthcare | Other | Nationwide |
| Drug | CLASS II | Ondansetron 8MG IN NS, antimetic recalled by Sentara Infusion Services | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Ondansetron HCL, Tab 8 mg filmcoated recalledOndansetron Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |