Ondansetron Injection (Baxter) – Failed pH Specs (2023)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
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.
Products Sold
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.
Baxter Healthcare Corporation is recalling Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter He due to Failed pH Specifications. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed pH Specifications
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026