Exela Pharma Sciences recalls

6 official recalls and safety alerts involving Exela Pharma Sciences since 2022-01, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Exela Pharma Sciences or the relevant agency.

1. 2025-09-17
2. US
   Drugs & medicalClass II

   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 Only,…

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

   FDA · DrugExela Pharma Sciences LLCNationwide in the USAOfficial notice →
3. 2025-04-02
4. US
   Drugs & medicalClass II

   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 Intravenous Use Only, Rx…

   Lack of Assurance of Sterility

   FDA · DrugExela Pharma Sciences LLCNationwideOfficial notice →
5. 2023-11-29
6. US
   Drugs & medicalClass I

   Exela Pharma Sciences LLC recalls ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion…

   Presence of Particulate Matter: Silicone

   FDA · DrugExela Pharma Sciences LLCNationwideOfficial notice →
7. 2022-12-21
8. US
   Drugs & medicalClass I

   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, Rx Only, Mfd…

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

   FDA · DrugExela Pharma Sciences LLCNationwide within the United StatesOfficial notice →
9. 2022-11-02
10. US
    Drugs & medicalClass I

    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, Rx only,…

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

    FDA · DrugExela Pharma Sciences LLCNationwide within the United StatesOfficial notice →
11. 2022-01-19
12. US
    Drugs & medicalClass II

    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: Exela Pharma…

    Lack of Assurance of Sterility

    FDA · DrugExela Pharma Sciences LLCNationwide within the United StatesOfficial notice →