CLASS II Drug recall · Reported 14 Sep 2016 · FDA Enforcement Report
Ondansetron Injection USP 40 mg/ (2 mg/mL) recalled
Teva North America is recalling Ondansetron Injection USP 40 mg/ (2 mg/mL), distributed nationwide in the US. The recall was initiated on 17 Jun 2016 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-1497-2016
- FDA event ID
- 74497
- Recalling firm
- Teva North America, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2016
- FDA classified
- 7 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 17 Jun 2016 | Recall initiated by company | |
| 7 Sep 2016 | Classified by FDA | +82 days |
| 14 Sep 2016 | 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
CGMP Deviations
Product as listed by the FDA
Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
All Lots Within Expiry Lot # 2930614, 2940614, 2950614
Where was it sold?
Nationwide and Puerto Rico
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.
Other products in this recall event
3 other products · FDA event 74497This product is part of a recall event; the main page for the event is Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Linezolid Injection 600 mg recalled by Teva North America | Teva North America | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Eptifibatide Injection 75 mg/ (0.75 mg/mL) single use vial recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Teva North America
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Claravis (isotretinoin capsules USP), 10mg recalled | Teva North America | Potency & Assay | Nationwide |
| Drug | CLASS II | Eptifibatide Injection 75 mg/ (0.75 mg/mL) single use vial recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Linezolid Injection 600 mg recalled by Teva North America | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Amoxicillin for Oral Suspension USP, 400 mg recalledAmoxicillin | Teva North America | Potency & Assay | 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 |