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Exela Pharma Sciences Recalls
12 recalls on record · May 30, 2018 to September 17, 2025 · Drugs
Recalls by year
18
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22
23
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 17, 2025DrugsFDA
Exela Pharma Sciences LLC recalls 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx O
Hazard: Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
April 2, 2025DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenou
Hazard: Lack of Assurance of Sterility
November 29, 2023DrugsFDA
Exela Pharma Sciences LLC recalls ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intraveno
Hazard: Presence of Particulate Matter: Silicone
November 29, 2023DrugsFDA
Exela Pharma Sciences LLC recalls Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to U
Hazard: Presence of Particulate Matter: Silicone
November 29, 2023DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Ca
Hazard: Presence of Particulate Matter: Silicone
December 21, 2022DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,
Hazard: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
December 21, 2022DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,
Hazard: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
November 2, 2022DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,
Hazard: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
November 2, 2022DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,
Hazard: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
January 19, 2022DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: E
Hazard: Lack of Assurance of Sterility
September 23, 2020DrugsFDA
Exela Pharma Sciences LLC recalls Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Scie
Hazard: Short Fill
May 30, 2018DrugsFDA
Exela Pharma Sciences LLC recalls Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla
Hazard: Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.