Heparin — Class I drug recall D-0649-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-09-11, distributed nationwide. Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
| Recall number | D-0649-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Round Lake, IL, United States |
| Recall initiated | 2024-08-01 |
| Classified | 2024-08-30 |
| Reported by FDA | 2024-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 44,208 containers |
| Reason classes | microbial contamination, sterility |
| NDC | 00338-0424, 00338-0424-18, 00338-0428, 00338-0428-12, 00338-0431, 00338-0431-03, 00338-0433, 00338-0433-04 |
| Lot numbers | N008235 |
| Expiration dates | 2024-08-31 |
Product
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
Reason for recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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-0649-2024. 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.