--- title: "Exela Pharma Sciences LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Exela Pharma Sciences LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/exela-pharma-sciences-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Exela Pharma Sciences LLC recall records **5** reported ongoing 10 records in this archive. Latest source date Jul 30, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 30, 2025 FDA drug enforcement ### [4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Scienc...](https://isitonrecall.com/recall/fda-drug-d-0620-2025-4-2-sodium-bicarbonate-injection-usp-5-meq-10-ml-0-5-meq-ml-for-intravenous-use-only-10-ml-single-do/) Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0620-2025%22) Mar 7, 2025 FDA drug enforcement ### [8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Scienc...](https://isitonrecall.com/recall/fda-drug-d-0303-2025-8-4-sodium-bicarbonate-injection-usp-50-meq-50-ml-1-meq-ml-25-x-50-ml-single-dose-vials-per-carton-f/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: Nationwide [Official source for 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0303-2025%22) Oct 18, 2023 FDA drug enforcement ### [8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials ...](https://isitonrecall.com/recall/fda-drug-d-0116-2024-8-4-sodium-bicarbonate-injection-usp-50-meq-50-ml-1meq-ml-a-20x50-ml-single-dose-vials-vial-ndc-5175/) Presence of Particulate Matter: Silicone Class I Reported ongoing Distribution: Nationwide [Official source for 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vi...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0116-2024%22) Oct 18, 2023 FDA drug enforcement ### [Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx On...](https://isitonrecall.com/recall/fda-drug-d-0117-2024-midazolam-in-0-8-sodium-chloride-injection-100-mg-100-ml-1mg-ml-100-ml-single-dose-vial-25-count-car/) Presence of Particulate Matter: Silicone Class I Reported ongoing Distribution: Nationwide [Official source for Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 c...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0117-2024%22) Oct 18, 2023 FDA drug enforcement ### [ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed b...](https://isitonrecall.com/recall/fda-drug-d-0118-2024-elcys-cysteine-hydrochloride-injection-usp-500-mg-10ml-50-mg-ml-10x10-ml-single-dose-sterile-vials-f/) Presence of Particulate Matter: Silicone Class I Reported ongoing Distribution: Nationwide [Official source for ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Steri...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0118-2024%22) Nov 28, 2022 FDA drug enforcement ### [8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma S...](https://isitonrecall.com/recall/fda-drug-d-0079-2023-8-4-sodium-bicarbonate-injection-usp-50-meq-50-ml-1-meq-ml-50-ml-single-dose-vials-packaged-in-carto/) Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. Class I Reported terminated Distribution: Nationwide within the United States [Official source for 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0079-2023%22) Nov 28, 2022 FDA drug enforcement ### [8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by:...](https://isitonrecall.com/recall/fda-drug-d-0080-2023-8-4-sodium-bicarbonate-injection-usp-50-meq-50-ml-1-meq-ml-50-ml-single-dose-vials-packaged-in-carto/) Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. Class I Reported terminated Distribution: Nationwide within the United States [Official source for 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0080-2023%22) Oct 4, 2022 FDA drug enforcement ### [8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma S...](https://isitonrecall.com/recall/fda-drug-d-0022-2023-8-4-sodium-bicarbonate-injection-usp-50-meq-50-ml-1-meq-ml-50-ml-single-dose-vials-packaged-in-carto/) Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration Class I Reported terminated Distribution: Nationwide within the United States [Official source for 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0022-2023%22) Oct 4, 2022 FDA drug enforcement ### [8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by:...](https://isitonrecall.com/recall/fda-drug-d-0023-2023-8-4-sodium-bicarbonate-injection-usp-50-meq-50-ml-1-meq-ml-50-ml-single-dose-vials-packaged-in-carto/) Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration Class I Reported terminated Distribution: Nationwide within the United States [Official source for 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0023-2023%22) Jan 11, 2022 FDA drug enforcement ### [8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5...](https://isitonrecall.com/recall/fda-drug-d-0369-2022-8-4-sodium-bicarbonate-injection-usp-50-meq-50-ml-1-meq-ml-50-ml-vials-rx-only-manufactured-and-dist/) Lack of Assurance of Sterility Class II Reported terminated Distribution: Nationwide within the United States [Official source for 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufacture...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0369-2022%22) ## Reasons in these listed records - Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. - Lack of Assurance of Sterility - Presence of Particulate Matter: Silicone - Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. These examples come from this result page and are not a ranking of every recall reason. ## Checking Exela Pharma Sciences LLC ### Is there a recall on exela pharma sciences llc right now? This archive contains 10 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Exela Pharma Sciences LLC](https://isitonrecall.com/check/?q=Exela%20Pharma%20Sciences%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)