Ondansetron Injection — Class II drug recall D-0146-2024
Completed recall by Baxter Healthcare Corporation, reported 2023-12-13, distributed nationwide. Failed pH Specifications
| Recall number | D-0146-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-11-14 |
| Classified | 2023-12-07 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 6,022,675 vials |
| NDC | 36000-0012, 36000-0012-25, 36000-0013, 36000-0013-01 |
| Lot numbers | A0E0959A, A0E0961A, A0E1015A, A0E1020A, A0F0016A, A0F0260A, A0F0261A, A0F0262A, A0F0414A, A0F0415A, A0F0416A, A0F0417A, A0F0418A, A0F0503A, A0F0533A, A0F0534A, A0F0535A, A0F0536A, A0F0537A, A0F0540A, A0F0541A, A0F0573A, A0F0574A, A0F0575A, A0F0592A, A0F0596A, A0F0599A, A0F0676A |
| Expiration dates | 2023-11-30, 2023-12-31, 2024-02-29, 2024-04-30, 2024-05-31, 2024-06-30, 2024-07-31, 2024-08-31 |
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
Reason for recall
Failed pH Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0146-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.