CLASS II Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report
Ondansetron Injection, USP, 4mg/, (2mg/ml) single-dose Fliptop Vial recalled
Hospira is recalling Ondansetron Injection, USP, 4mg/, (2mg/ml) single-dose Fliptop Vial, distributed nationwide in the US. The recall was initiated on 20 May 2013 and the FDA has classified it as Class II.
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-851-2013
- FDA event ID
- 65300
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Ondansetron
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 May 2013
- FDA classified
- 7 Aug 2013
- Reported
- 14 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 20 May 2013 | Recall initiated by company | |
| 7 Aug 2013 | Classified by FDA | +79 days |
| 14 Aug 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Product as listed by the FDA
Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Which lots are affected?
Lot 25394DK, exp. 01/2015
Where was it sold?
Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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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 |