Sodium Bicarbonate Injection Recalled Over Arsenic Impurity Concerns

Exela Pharma Sciences LLC has initiated a voluntary nationwide recall of its 4.2% Sodium Bicarbonate Injection, USP, packaged in 10 mL single-dose vials for intravenous use. The recall, listed under recall number D-0620-2025, affects Lot #10004077, which carries an expiration date of February 28, 2026. According to the US Food and Drug Administration (FDA) Enforcement Report, the recall was classified as a Class II recall, which indicates that exposure to the affected product could cause temporary or medically reversible adverse health consequences, though the likelihood of serious harm is remote. The recall was formally initiated on July 30, 2025, and remains ongoing.

The decision to recall was made after the lot in question failed to meet impurities/degradation specifications, specifically due to out-of-specification results for arsenic during testing. The company notified consignees and the public through multiple communication channels, including email, fax, letters, and direct outreach. No press release has been issued for this recall, and the total quantity of product affected has not been disclosed. The FDA classified the recall on September 5, 2025.

Sodium Bicarbonate Injection, USP is commonly used in clinical practice to treat metabolic acidosis, a condition characterized by an excess of acid in the body due to kidney disease, shock, severe dehydration, uncontrolled diabetes, or certain drug toxicities. Pharmacists should be aware of this recall as it directly impacts hospital and acute care settings where rapid administration of sodium bicarbonate is sometimes critical. Health care providers should check their inventory for the recalled lot number and follow FDA guidance to ensure patient safety.