Heparin Sodium 2 — Class II drug recall D-0097-2023
Completed recall by Pfizer Inc., reported 2023-01-11, distributed nationwide. Lack of assurance of sterility: Bags have the potential to leak.
| Recall number | D-0097-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2022-12-29 |
| Classified | 2023-01-05 |
| Reported by FDA | 2023-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 62,088 bags |
| Reason classes | sterility, packaging |
| NDC | 00409-1005, 00409-1005-01, 00409-1005-20, 00409-2222, 00409-2222-01, 00409-2222-12, 00409-7620, 00409-7620-03, 00409-7620-13, 00409-7620-49, 00409-7620-59 |
| Lot numbers | 5935283 |
| Expiration dates | 2023-12-01 |
Product
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
Reason for recall
Lack of assurance of sterility: Bags have the potential to leak.
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-0097-2023. 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.