FDA Drug recall D-0591-2025
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-66…
- FDA Drug
- Class II
- ongoing
- Published 2025-08-27
On 2025-08-27 the FDA classified a Class II recall of Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-66… by Pfizer, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0591-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-04 |
| Published | 2025-08-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
Product
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
Reason
Lack of Assurance of Sterility.
Identifiers
| ndc | 0409-4916-24 |
|---|---|
| ndc | 0409-4916-14 |
| ndc | 0409-6637-24 |
| ndc | 0409-6637-14 |
| ndc | 00409-6637-14 |
| code_info | Lot #: LH2671, Exp. 11/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0591-2025%22
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