FDA Recalls Sodium Bicarbonate Injection Due to Arsenic Contamination
Exela Pharma Sciences LLC is recalling one lot of Sodium Bicarbonate Injection due to arsenic contamination detected during quality testing. The product is administered intravenously and was distributed nationwide.
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: This is a Class II recall of an injectable pharmaceutical containing arsenic above USP specifications. Arsenic is a high-risk toxin posing significant harm when present in a product administered directly to the bloodstream. No illnesses or adverse events have been reported, making this a risk-of-harm recall where injury has not yet been reported.
Plain-English summary
Exela Pharma Sciences LLC is recalling Sodium Bicarbonate 4.2% Injection, USP (5 mEq/10 mL) in 10 mL single-dose vials for intravenous use. The affected lot is #10004077, with an expiration date of February 28, 2026.
The recall was initiated because quality testing revealed that the lot does not meet U.S. Pharmacopeial specifications for impurities. Specifically, arsenic levels were found to exceed the established safety limits for this injectable medication.
The affected product was distributed nationwide. Healthcare providers and patients who have this lot should discontinue use and consult their healthcare provider. The lot can be identified by lot number 10004077 and expiration date 02/28/2026 on the vial label.
The recalled product
- Product
- SODIUM BICARBONATE (SODIUM BICARBONATE)
- Brand
- SODIUM BICARBONATE
- Manufacturer
- Exela Pharma Sciences LLC
- Category
- Drug
- Hazard
- arsenic-contamination
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 # 10004077
- Exp. 02/28/2026
Distribution
Distributed nationwide across the United States.
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