Exela Pharma Sciences recalls
Exela Pharma Sciences appears in 12 official U.S. recall notices indexed by RecallRadar, most recently on 2025-09-17.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 12 |
|---|---|
| Published | 2018-05-30 to 2025-09-17 |
| By agency | FDA Drug (12) |
| By classification | Class I (7), Class II (4), Class III (1) |
| By status | terminated (7), ongoing (5) |
| Distribution named in notices | US |
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 Only, Manufactured a…
FDA Drug · Class II · 2025-09-17 · Exela Pharma Sciences
Reason: Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. - 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…
FDA Drug · Class II · 2025-04-02 · Exela Pharma Sciences
Reason: Lack of Assurance of Sterility - 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1
FDA Drug · Class I · 2023-11-29 · Exela Pharma Sciences
Reason: Presence of Particulate Matter: Silicone - ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, R…
FDA Drug · Class I · 2023-11-29 · Exela Pharma Sciences
Reason: Presence of Particulate Matter: Silicone - 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…
FDA Drug · Class I · 2023-11-29 · Exela Pharma Sciences
Reason: Presence of Particulate Matter: Silicone - 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, Manufactu…
FDA Drug · Class I · 2022-12-21 · Exela Pharma Sciences
Reason: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. - 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:…
FDA Drug · Class I · 2022-12-21 · Exela Pharma Sciences
Reason: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. - 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:…
FDA Drug · Class I · 2022-11-02 · Exela Pharma Sciences
Reason: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration - 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, Manufactu…
FDA Drug · Class I · 2022-11-02 · Exela Pharma Sciences
Reason: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration - 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Science…
FDA Drug · Class II · 2022-01-19 · Exela Pharma Sciences
Reason: Lack of Assurance of Sterility - Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, N…
FDA Drug · Class III · 2020-09-23 · Exela Pharma Sciences
Reason: Short Fill - Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India
FDA Drug · Class II · 2018-05-30 · Exela Pharma Sciences
Reason: 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.