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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. Source coverage and dates.

Records and reported status

Jul 30, 2025FDA 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...

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Mar 7, 2025FDA 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...

Lack of Assurance of Sterility

Class IIReported ongoing

Distribution: Nationwide

Official source

Oct 18, 2023FDA 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 ...

Presence of Particulate Matter: Silicone

Class IReported ongoing

Distribution: Nationwide

Official source

Oct 18, 2023FDA 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...

Presence of Particulate Matter: Silicone

Class IReported ongoing

Distribution: Nationwide

Official source

Oct 18, 2023FDA 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...

Presence of Particulate Matter: Silicone

Class IReported ongoing

Distribution: Nationwide

Official source

Nov 28, 2022FDA 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...

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Class IReported terminated

Distribution: Nationwide within the United States

Official source

Nov 28, 2022FDA 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:...

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Class IReported terminated

Distribution: Nationwide within the United States

Official source

Oct 4, 2022FDA 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...

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Class IReported terminated

Distribution: Nationwide within the United States

Official source

Oct 4, 2022FDA 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:...

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Class IReported terminated

Distribution: Nationwide within the United States

Official source

Jan 11, 2022FDA 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...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide within the United States

Official source

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.

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Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

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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 and the agency's current notices.

Where can I find older records?

Use monthly 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.

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