Heparin Sodium Injection — Class II drug recall D-0435-2023
Terminated recall by Sagent Pharmaceuticals Inc, reported 2023-03-15, distributed nationwide. Labeling: Not elsewhere classified
| Recall number | D-0435-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals Inc, Schaumburg, IL, United States |
| Recall initiated | 2023-02-28 |
| Classified | 2023-03-06 |
| Reported by FDA | 2023-03-15 |
| Terminated | 2026-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 28,875 vials |
| Reason classes | labeling |
| NDC | 25021-0404, 25021-0404-01 |
| Lot numbers | WP201 |
| Expiration dates | 2024-02 |
Product
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01
Reason for recall
Labeling: Not elsewhere classified
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-0435-2023. 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.