On October 25, 2023, the U.S. Food and Drug Administration (FDA) announced that Exela Pharma Sciences, LLC (Exela), is voluntarily recalling the following products to the consumer level because it observed silicone particulate matter during routine inspection of retained samples.

FDA update

Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. In some cases, it may also block blood vessels in the heart, lungs, or brain, which can cause stroke and even lead to death. Exela has not received any reports of adverse events related to the recall.



Single-Dose Vial Size

8.4% sodium bicarbonate
injection, USP

50 mEq/50 ml

50 ml

Midazolam in 0.8% sodium
chloride injection

100 mg/100 ml

100 ml

Cysteine hydrochloride
injection, USP

500 mg/10 ml

10 ml

8.4% Sodium Bicarbonate Injection USP 

Used for the treatment of metabolic acidosis, the product is packaged in a 50 ml single-dose glass vial. The Exela brand contains either 20 (carton NDC = 51754-5001-5, vial NDC = 51754-5001-1) or 25 (carton NDC = 51754-5001-4, vial NDC = 51754-5001-1) vials per carton. The Civica brand (carton NDC = 72572-740-20, vial NDC = 72572-740-01) contains 25 vials per carton.

Civica lot P0001912, expiration date 08/2024, and the following Exela lots are affected.




















All of the products were distributed nationwide to wholesalers, distributors, and health systems from January 18, 2022–February 15, 2023.

Midazolam in 0.8% Sodium Chloride Injection 

Used for sedation and packaged in a 100 ml glass vial, 25 vials per corrugated shipper, the affected midazolam in 0.8% sodium chloride injection vials are labeled with Exela brand (carton NDC = 51754-2131-4, vial NDC = 51754-2131-1).

Excela lot 10001088 of midazolam in 0.8% sodium chloride injection 100 mg/100 ml, expiration date 07/2024, is affected. The vials were distributed nationwide to wholesalers, distributors, and health systems from July 14–September 26, 2023.

Cysteine Hydrochloride Injection 

Used for total parenteral nutritional requirements and packaged in a 10 ml glass vial, 10 vials per carton, the affected product was distributed under Exela brand carton NDC 51754-1007-3 and vial NDC 51754-1007-1, lot 10000798, with a 3/2025 expiration date. The cartons were distributed nationwide to wholesalers, distributors, health systems, and compounders from July 20–August 1, 2023.

Customer Action

Exela said that it is notifying its customers about the recall by email and certified mail and is arranging for return and replacement of all recalled products. Customers who have the recalled product should discontinue use; segregate any remaining inventory’ submit a recall stock response form to Exela, even if no inventory remains; and hold the product until Exela can provide shipment instructions.

Customers with questions regarding the recall should contact Exela at 828-341-6118 or recall@exela.us, Monday–Friday, 9 am–5 pm ET. Consumers should contact their physician or healthcare provider if they experience any problems related to the product.

Healthcare professionals should report any adverse reactions or quality problems experienced with the use of this product to FDA’s MedWatch Adverse Event Reporting program.