Pfizer Recalls Sodium Bicarbonate Injection Due to Sterility Assurance Concerns
Pfizer is recalling 15,750 vials of Sodium Bicarbonate Injection (8.4%, 50mEq/50mL) distributed nationwide due to lack of assurance of sterility. Lot LH2671, expiring 11/30/2026, may not meet required sterility standards for injectable medications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an injectable drug with lack of assurance of sterility, a risk-of-harm hazard. No illnesses, injuries, hospitalizations, or deaths have been reported, and the hazard is theoretical rather than confirmed. Per the rubric, unconfirmed sterility hazards without reported harm score at most 3.
Plain-English summary
Pfizer is recalling Sodium Bicarbonate Injection, USP, 8.4% strength (50 mEq/50 mL), a prescription injectable medication used to treat metabolic acidosis. The recall affects 15,750 vials from lot LH2671, which expire on November 30, 2026, and were distributed nationwide.
The manufacturer initiated the recall because it cannot assure that the affected vials meet the sterility standards required for injectable products. Intravenous medications must be completely sterile to prevent serious infections. No contamination has been confirmed, and no illnesses or injuries have been reported.
Healthcare providers, pharmacies, and hospitals should stop using affected vials immediately and quarantine them. Patients who have received this medication should contact their healthcare provider if they develop signs of infection such as fever or chills.
The recalled product
- Product
- SODIUM BICARBONATE (SODIUM BICARBONATE)
- Brand
- SODIUM BICARBONATE
- Manufacturer
- PFIZER INC
- Hazard
- sterility-assurance
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: LH2671
- Exp. 11/30/2026
Distribution
Distributed nationwide across the United States.
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