The Recall Desk

Manufacturer

Exela Pharma Sciences LLC

12 recalls in our database name Exela Pharma Sciences LLC as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
8
Most recent
2025-09-17

Of the 12 recalls from Exela Pharma Sciences LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (67%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

  • HighFDA (Drugs)·D-0303-2025·2025-04-02

    Sodium Bicarbonate Injection Recalled Due to Sterility Assurance Issue

    Exela Pharma Sciences is recalling Sodium Bicarbonate 8.4% Injection due to lack of sterility assurance. The recall affects approximately 103,950 vials nationwide.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0117-2024·2023-11-29

    Midazolam Injectable Recalled for Silicone Particulate Matter Contamination

    Exela Pharma Sciences is recalling Midazolam Injectable due to silicone particulate matter contamination. Patients and healthcare providers with the affected lot should discontinue use and consult their healthcare provider.

    Product
    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 Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0116-2024·2023-11-29

    FDA Recalls Sodium Bicarbonate Injection for Silicone Particulate Contamination

    Exela Pharma Sciences recalls 8.4% sodium bicarbonate injection nationwide due to silicone particulate matter in vials. The FDA classified this Class I recall as affecting 355,220 vials.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0079-2023·2022-12-21

    FDA Recalls Sodium Bicarbonate Injection for Defective Vials

    Exela Pharma Sciences is recalling 489,600 vials of sodium bicarbonate injection nationwide due to defective vials that break and release glass fragments when pressurized during preparation.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0080-2023·2022-12-21

    FDA Recalls Sodium Bicarbonate Injection Vials for Glass Breakage Risk

    Exela Pharma Sciences is recalling Sodium Bicarbonate Injection vials due to defective containers that may break and release glass fragments when pressurized during preparation. The recall affects 37,320 vials distributed nationwide.

    Product
    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: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0023-2023·2022-11-02

    Sodium Bicarbonate Injection Recalled for Defective Vials and Glass Breakage

    Nationwide recall of 8.4% sodium bicarbonate injection vials due to container defects causing vial breakage and glass fragments when pressurized during preparation.

    Product
    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: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0022-2023·2022-11-02

    Sodium Bicarbonate Injection Recalled for Defective Vials with Glass Breakage Risk

    Exela Pharma Sciences is recalling 2,123,040 vials of Sodium Bicarbonate 8.4% Injection due to container defects causing vial breakage and glass release when pressurized during product preparation.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0369-2022·2022-01-19

    Exela Sodium Bicarbonate Injection Recalled for Sterility Assurance Failure

    Exela Pharma Sciences is recalling 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The affected lot (C0001088/P0001317, expiring 08/2023) was distributed nationwide.

    Product
    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 51754-5001-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1585-2020·2020-09-23

    Exela Pharma Recalls Potassium Acetate Injection Vials Due to Short Fill

    Exela Pharma Sciences LLC is voluntarily recalling 23,775 vials of Potassium Acetate Injection, USP due to short fill issues.

    Product
    Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0826-2018·2018-05-30

    Exela Pharma Recalls Diclofenac and Misoprostol Tablets Due to Labeling Error

    Exela Pharma Sciences LLC is recalling 5,256 bottles of Diclofenac Sodium and Misoprostol tablets because some bottles were mislabeled with the wrong dosage.

    Product
    Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.
    Category
    Drug
    Distribution
    Distributed nationwide