Exela Pharma Sciences LLC

FDA recalling firm · 8 enforcement events · 12 product records · 2018–2025 · NC

Exela Pharma Sciences LLC has 8 FDA enforcement events on this register (12 product records) between 2018 and 2025: 8 drug; the busiest year was 2022 with 3.

38% of its events are Class I; the most common class is Class II (4). 3 events are listed as ongoing; the recalling firm's address is in NC.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
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 Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)	Drug	Class II	1	Ongoing
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 Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4	Drug	Class II	1	Ongoing
18 Oct 2023	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,…	Drug	Class I	3	Ongoing
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, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.	Drug	Class I	2	Terminated
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, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1	Drug	Class I	2	Terminated
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: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1	Drug	Class II	1	Terminated
5 May 2020	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	Drug	Class III	1	Terminated
20 Apr 2018	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.	Drug	Class II	1	Terminated

By type and class

Drug8

Class II4

Class I3

Class III1

Class I: 38% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Exela Pharma Sciences LLC by year initiated.

Questions and answers

How many FDA recalls has Exela Pharma Sciences LLC had?

8 enforcement events (12 product records) on this register, 2018–2025: 8 drug.

Are any Exela Pharma Sciences LLC recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are Exela Pharma Sciences LLC recalls?

4 Class II, 3 Class I, 1 Class III. 38% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.