Hospira Recalls Sodium Bicarbonate Injection Due to Sterility Risk
Hospira recalls 8.4% Sodium Bicarbonate Inj., USP due to lack of sterility assurance. Check lot numbers and expiration dates for affected vials.
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Lack of Sterility Assurance
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What happened, in plain English
Hospira, a Pfizer company, is recalling specific lots of 8.4% Sodium Bicarbonate Injection, USP because the products may not be sterile. This recall affects over 91 million single-dose vials distributed in the U.S., Canada, and other regions. The lack of sterility assurance poses a risk to patients who might use these contaminated injections. Read more at govinfonow.com/recall/41559-hospira-recalls-sodium-bicarbonate-injection-due-to-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41559-hospira-recalls-sodium-bicarbonate-injection-due-to-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-1047-2017
Cite this page
“Hospira Recalls Sodium Bicarbonate Injection Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41559-hospira-recalls-sodium-bicarbonate-injection-due-to-sterility-risk. Based on FDA recall #D-1047-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1047-2017%22&limit=1).
Why it’s dangerous
The recall is due to a lack of sterility assurance, meaning the vials may contain harmful microorganisms. Using non-sterile injections can lead to serious infections or other adverse health effects in patients.
Who’s affected
Healthcare facilities and patients in the U.S., Puerto Rico, Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore who received the recalled lots. Patients receiving this specific injection are at risk of infection due to potential contamination.
How to tell if you have this one
Check if you have 8.4% Sodium Bicarbonate Inj., USP 50 mL single-dose vials manufactured by Hospira, INC, Lake Forest, IL. Look for NDC 0409-6625-02 and the following lot numbers: 72109EV, 72110EV, 72112EV, 72113EV, 72114EV, 73068EV, 73071EV, 73072EV, 73224EV, 73225EV, 73230EV, 73231EV, 73232EV, 73233EV, 73234EV, 73235EV, 73236EV, 73298EV, 74058EV, 74104EV, 74105EV, 74106EV, 74107EV, 74197EV, 74198EV, 74199EV, 74200EV, 74201EV, 75171EV, 75172EV, 75173EV, 75174EV, 75175EV, 75176EV, 75177EV, 75178EV, 75293, 75418EV, and 75419EV.
- Brand
Hospira- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1046-2017 | Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01; Lot: 74119EV Exp. 02/01/2019 Lot: 74120EV Exp. 02/01/2019 Lot: 74121EV Exp. 02/01/2019 Lot: 74307EV Exp. 02/01/2019 Lot: 75326EV Exp. 03/01/2019 Lot: 75327EV Exp. 03/01/2019 Lot: 75215EV Exp. 03/01/2019 | 20,337,650 15 mL single dose vials | — |
| D-1047-2017 | 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02; Lot: 72109EV Exp. 12/01/2018, Lot: 72110EV Exp. 12/01/2018, Lot: 72112EV Exp. 12/01/2018, Lot: 72113EV Exp. 12/01/2018, Lot: 72114EV Exp. 12/01/2018, Lot: 73068EV Exp. 01/01/2019, Lot: 73071EV Exp. 01/01/2019, Lot: 73072EV Exp. 01/01/2019, Lot: 73224EV Exp. 01/01/2019, Lot: 73225EV Exp. 01/01/2019, Lot: 73230EV Exp. 01/01/2019, Lot: 73231EV Exp. 01/01/2019, Lot: 73232EV Exp. 01/01/2019, Lot: 73233EV Exp. 01/01/2019, Lot: 73234EV Exp. 01/01/2019, Lot: 73235EV Exp. 01/01/2019, Lot: 73236EV Exp. 01/01/2019, Lot: 73298EV Exp. 01/01/2019, Lot: 74058EV Exp. 02/01/2019, Lot: 74104EV Exp. 02/01/2019, Lot: 74105EV Exp. 02/01/2019, Lot: 74106EV Exp. 02/01/2019, Lot; 74107EV Exp. 02/01/2019, Lot: 74197EV Exp. 02/01/2019, Lot: 74198EV Exp. 02/01/2019, Lot: 74199EV Exp. 02/01/2019, Lot: 74200EV Exp. 02/01/2019, Lot: 74201EV Exp. 02/01/2019, Lot: 75171EV Exp. 03/01/2019, Lot: 75172EV Exp. 03/01/2019, Lot: 75173EV Exp. 03/01/2019, Lot: 75174EV Exp. 03/01/2019, Lot: 75175EV Exp. 03/01/2019, Lot: 75176EV Exp. 03/01/2019, Lot: 75177EV Exp. 03/01/2019, Lot: 75178EV Exp. 03/01/2019. Lot: 75293 Exp. 03/01/2019, Lot: 75418EV Exp. 03/01/2019, Lot: 75419EV Exp. 03/01/2019 | 91,483,150 50 mL single dose vials | — |
| D-1048-2017 | Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25).; a.) one vial Lot: 74393EV Exp. 05/01/2018 Lot: 75157EV Exp. 06/01/2018 Lot: 75367EV, Exp. 06/01/2018 b.) 25 vial carton Lot: 75158EV; Exp. 06/01/2018 | 15,034,600 10 mL multiple dose use vials | 0409-6629-12, 0409-6629-02, 0409-6970-10, 0409-6629-25 |
| D-1049-2017 | Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA; a.) one vial: Lot: 72226EV Exp. 12/01/2018 Lot: 72236EV Exp. 12/01/2018 Lot: 75382EV Exp. 03/01/2019 Lot: 75383EV Exp. 03/01/2019 b.) 25 vial carton: Lot: 7538EV; Exp 03/01/2019 | 21,436,700 5mL single dose vials | — |
What to do — step by step
Stop using the product
Do not use any vials matching the recalled lot numbers due to sterility risks.
Contact your supplier
Reach out to your distributor or Hospira for instructions on returning or disposing of the product, as specific remedy details are not provided in this record.
Where it went and when
Where it was distributed
Distributed in Puerto Rico, and outside the U.S.
FDA distribution: “U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Puerto Rico.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many vials are being recalled?
Approximately 91,483,150 single-dose vials are included in this recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1047-2017 (June 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1047-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.