Food, drugs, devices › Exela Pharma Sciences LLC

Drug recall: 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Ca

FDA enforcement event 93265 · Class I · initiated 18 Oct 2023 · status Ongoing

DrugVoluntary: Firm initiated3 product recordsLenoir, NC

Exela Pharma Sciences LLC (Lenoir, NC) initiated this drug recall on 18 Oct 2023; FDA lists 3 product records under event 93265, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 15% of the 281 drug enforcement events initiated in 2023 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Exela Pharma Sciences LLC has 8 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Exela Pharma Sciences LLC, Lenoir, NC.

Reason for recall

"Presence of Particulate Matter: Silicone"

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0116-2024	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 (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences,…	355,220 vials	Class I	Ongoing	29 Nov 2023
D-0117-2024	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 51754-2131-1; Carton NDC 51754-2131-4).	23,425 vials	Class I	Ongoing	29 Nov 2023
D-0118-2024	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 by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).	38,200 vials	Class I	Ongoing	29 Nov 2023

Context

15%of 2023 drug events are Class I281 events that year

3product records in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for Exela Pharma Sciences LLC

Initiated	Product (first record)	Type	Class	Records
30 Jul 2025	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	Drug	Class II	1
7 Mar 2025	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenou	Drug	Class II	1
28 Nov 2022	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,	Drug	Class I	2
4 Oct 2022	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,	Drug	Class I	2
11 Jan 2022	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: E	Drug	Class II	1
5 May 2020	Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Scien	Drug	Class III	1
20 Apr 2018	Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla	Drug	Class II	1

All 8 events for Exela Pharma Sciences LLC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Presence of Particulate Matter: Silicone"

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.