Quick Facts at a Glance
- Recall Date
- August 4, 2025
- Hazard Level
- HIGH
- Brands
- Hospira, Pfizer
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Hospira, Pfizer
- Product type
- Vial of injectable solution
- Model numbers
- LH2671 Exp. 11/30/2026
- UPC codes
- 0409-4916, 0409-6637, 0409-4916-24, 0409-4916-14, 0409-6637-24, 0409-6637-14, 00409-6637-14
- Sizes
- 50 mL
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 4, 2025
Reported by FDA DRUG
August 27, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact PFIZER INC or your healthcare provider for guidance. Notification method: Letter
About This Product
Hospira 8.4% Sodium Bicarbonate Injection is an intravenous solution used in clinical settings as a buffering agent or to correct acidosis.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare facilities may need to discard affected lots, affecting supply and budgeting. Patients could face delays in treatment if supplies are quarantined.
Practical Guidance
How to identify if yours is affected
- Check vial label for 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL
- Look for Lot LH2671 and Exp. 11/30/2026
Where to find product info
FDA enforcement report D-0591-2025 and FDA recall page
What timeline to expect
Remedies and replacements are coordinated by Pfizer and may take weeks to months depending on supply
If the manufacturer is unresponsive
- Escalate to regulatory authorities
- File a consumer complaint with CPSC if applicable
- Document all communications and keep records
How to prevent similar issues
- Strengthen sterilization validation
- Increase batch testing
- Track lot-level distribution to minimize impact
- Audit suppliers for sterility assurances
Documentation advice
Keep copy of recall notices, lot numbers, and any medical records related to exposure or administration
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Product Details
Brand: Hospira. Product: 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL). Case NDC: 00409-6637-14. NDC: 0409-6637-24. Lot: LH2671. Expiration: 11/30/2026. Quantity: 15,750 vials. Distribution: U.S. Nationwide.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Countrywide distribution in the U.S.
- Lot LH2671, Expiration 11/30/2026
- Class II recall
- High hazard level
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Safety Guide
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