CLASS II Drug recall · Reported 13 Dec 2023 · FDA Enforcement Report

Ondansetron Injection, USP, 4 mg/ (2 mg/mL) per vial recalled

Baxter Healthcare is recalling Ondansetron Injection, USP, 4 mg/ (2 mg/mL) per vial, distributed nationwide in the US. The recall was initiated on 14 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # A0E0959A, A0E0961A, A0E1015A, A0E1020A, Exp. Date 30-Nov-23; A0F0016A, Exp. Date 31-Dec-23; A0F0260A, A0F0261A, A0F0262A, Exp. Date 29-Feb-24; A0F0414A, A0F0415A, A0F0416A, A0F0417A, A0F0418A, Exp. Date 30-Apr-24; A0F0503A, Exp. Date 31-May-24, A0F0533A, A0F0534A, A0F0535A, A0F0536A, A0F0537A, A0F0540A, A0F0541A, Exp. Date 30-Jun-24; A0F0573A, A0F0574A, A0F0575A, A0F0592A, Exp. Date 31-Jul-24; A0F0596A, A0F0599A, Exp. Date 31-Aug-24 ; A0F0676A, 31-Oct-24.

NDC36000-012, 36000-013

UPC0336000012256

Quantity recalled6,022,675 vials

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-0146-2024
FDA event ID: 93359
Recalling firm: Baxter Healthcare, Deerfield, IL
Brand: Ondansetron Hydrochloride
Manufacturer: Baxter Healthcare Corporation
Classification: Class II
Status: Completed
Recall initiated: 14 Nov 2023
FDA classified: 7 Dec 2023
Reported: 13 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Stomach & Acid Reflux Medication

Timeline

14 Nov 2023	Recall initiated by company
7 Dec 2023	Classified by FDA	+23 days
13 Dec 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed pH Specifications

Product as listed by the FDA

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Failed pH Specifications

Which lots are affected?

Lot # A0E0959A, A0E0961A, A0E1015A, A0E1020A, Exp. Date 30-Nov-23; A0F0016A, Exp. Date 31-Dec-23; A0F0260A, A0F0261A, A0F0262A, Exp. Date 29-Feb-24; A0F0414A, A0F0415A, A0F0416A, A0F0417A, A0F0418A, Exp. Date 30-Apr-24; A0F0503A, Exp. Date 31-May-24, A0F0533A, A0F0534A, A0F0535A, A0F0536A, A0F0537A, A0F0540A, A0F0541A, Exp. Date 30-Jun-24; A0F0573A, A0F0574A, A0F0575A, A0F0592A, Exp. Date 31-Jul-24; A0F0596A, A0F0599A, Exp. Date 31-Aug-24 ; A0F0676A, 31-Oct-24.

Where was it sold?

Nationwide in the USA

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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7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
24 Dec 2025Drug	CLASS II	Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled	Preferred Pharmaceuticals	Packaging Defects	CA
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15 Jun 2022Drug	CLASS II	Ondansetron HCL, Tab 8 mg filmcoated recalledOndansetron Hydrochloride	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
1 Jun 2022Drug	CLASS II	Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose vial recalled	Olympia Compounding Pharmacy	Sterility	Nationwide