Exela Pharma recalls 10mL IV sodium bicarbonate vials with arsenic impurities. This injection for medical use may have unsafe levels of arsenic that could cause harm if used improperly.
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Exela Pharma is recalling 10mL single-dose vials of 4.2% sodium bicarbonate injection for IV use due to arsenic impurities. This could pose a health risk if the medication is administered improperly.
The injection may contain unsafe levels of arsenic as a contaminant. Arsenic is a toxic substance that could cause harm if the medication is administered improperly.
Healthcare professionals who use this medication for intravenous treatments. Patients receiving this injection under medical supervision are not directly affected.
Check for vials labeled '4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only'. The NDC number 51754-5012-1 (vial) or 51754-5012-4 (carton) with lot number 10004077.
Look for the NDC number 51754-5012-1 (vial) or 51754-5012-4 (carton) with lot number 10004077.
The product has been recalled due to potential arsenic impurities, which could pose a health risk if used improperly. Do not use until the recall is resolved.
Healthcare professionals who have this product for intravenous use should stop using it until the recall is resolved.
Check the vial label for NDC number 51754-5012-1 (vial) or 51754-5012-4 (carton) with lot number 10004077.
We’ve drafted a message you can send Exela Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0620-2025 — Exela Pharma Exela Pharma Hello, I own a Exela Pharma that is covered by recall D-0620-2025 from Exela Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
