Exela Pharma Sciences recalls

Exela Pharma Sciences has 12 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 17 Sep 2025. 5 are still ongoing. The most frequent reason is foreign material.

Total recalls12since 2018

Last 12 months0reported

Class I758% of total

Ongoing5latest 17 Sep 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 1Apr 0 0 0Jul 0 1 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 7 58%Class II 4 33%Class III 1 8%

Why exela pharma sciences is recalled

Product types

Injectable & IV Drugs1192%
Pain Medication18%

Brands

Sodium Bicarbonate542%
Elcys18%

By year

2025217%
2023325%
2022542%
202018%
201818%

Ongoing exela pharma sciences recalls

5 active

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Drug	CLASS II	2% Sodium Bicarbonate Injection, USP, 5 mEq/ 5 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Lead & Heavy Metals	Nationwide
2 Apr 2025Drug	CLASS II	4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Midazolam in 8% Sodium Chloride Injection 100 mg recalled	Exela Pharma Sciences	Particulate Matter	Nationwide
29 Nov 2023Drug	CLASS I	4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Particulate Matter	Nationwide
29 Nov 2023Drug	CLASS I	Elcys (cysteine hydrochloride injection), USP, 500 mg recalledElcys	Exela Pharma Sciences	Particulate Matter	Nationwide

All exela pharma sciences recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Drug	CLASS II	2% Sodium Bicarbonate Injection, USP, 5 mEq/ 5 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Lead & Heavy Metals	Nationwide
2 Apr 2025Drug	CLASS II	4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Midazolam in 8% Sodium Chloride Injection 100 mg recalled	Exela Pharma Sciences	Particulate Matter	Nationwide
29 Nov 2023Drug	CLASS I	4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Particulate Matter	Nationwide
29 Nov 2023Drug	CLASS I	Elcys (cysteine hydrochloride injection), USP, 500 mg recalledElcys	Exela Pharma Sciences	Particulate Matter	Nationwide
21 Dec 2022Drug	CLASS I	4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium Bicarbonate	Exela Pharma Sciences	Foreign Material	Nationwide
21 Dec 2022Drug	CLASS I	4% Sodium Bicarbonate Injection, USP 50 mEq recalled	Exela Pharma Sciences	Foreign Material	Nationwide
2 Nov 2022Drug	CLASS I	4% Sodium Bicarbonate Injection, USP 50 mEq recalled	Exela Pharma Sciences	Foreign Material	Nationwide
2 Nov 2022Drug	CLASS I	4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium Bicarbonate	Exela Pharma Sciences	Foreign Material	Nationwide
19 Jan 2022Drug	CLASS II	4% Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) vials recalled	Exela Pharma Sciences	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.