Exela Pharma Sciences recalled 4.2% Sodium Bicarbonate Injection on July 30, 2025, due to arsenic contamination. The recall affects single-dose vials distributed nationwide. Consumers and healthcare providers must stop using the product immediately.
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Consumers and healthcare providers should stop using this product immediately. Contact Exela Pharma Sciences LLC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
This recall involves 4.2% Sodium Bicarbonate Injection, USP, in a 10 mL single-dose vial. The affected lot number is 10004077 with an expiration date of February 28, 2026.
The product failed impurities and degradation specifications, showing out-of-specification results for arsenic. Such contamination poses serious health risks to consumers.
There have been no reported incidents or injuries linked to this recall. However, the potential health risks associated with arsenic exposure are significant.
Stop using the sodium bicarbonate injection immediately. Contact Exela Pharma Sciences LLC or your healthcare provider for further guidance.
For more information, visit Exela Pharma Sciences' website or call their customer service number. Details can also be found on the FDA enforcement page.
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