Exela Pharma Sciences LLC recalls
Every recall we track for Exela Pharma Sciences LLC — 12 in all, from 2018–2025 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Exela Pharma Sciences LLC peaked in 2022 (5); 12 since 2017. 33% rated “stop using now”.
All FDA recall records for Exela Pharma Sciences LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 2 | 2 | 0 | 1 | 5 |
| 2023 | 2 | 1 | 0 | 0 | 3 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 1 | 2 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Exela Pharma Sciences LLC recalls
What to do if you have a recalled Exela Pharma Sciences LLC product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Exela Pharma Sciences LLC recalls
8 shown- Lower riskDrug
Exela Pharma Sciences LLC recalls 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx
Exela Pharma recalls 10mL IV sodium bicarbonate vials with arsenic impurities. This injection for medical use may have unsafe levels of arsenic that could cause harm if used improperly.
Exela PharmaJul 30, 2025 - UnratedDrug
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For
Exela Pharma Sciences recalls 25 x 50 mL vials of 8.4% Sodium Bicarbonate Injection due to lack of sterility assurance. This injectable medication is for IV use only and requires immediate action to prevent infection risks.
ExelaMar 7, 2025 - Stop using nowDrug
Exela Pharma Sciences LLC recalls ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For
Exela Pharma Sciences recalls 10x10mL ELCYS vials due to silicone particles that could cause blockages or reactions when injected. Affected lots manufactured in 2023.
ExelaOct 18, 2023 - Use cautionDrug
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20
Exela Pharma Sciences recalls 50mL sodium bicarbonate vials due to breakage and glass flying when pressurized during administration. Affected vials were packaged in cartons of 20 with specific lot numbers.
ExelaNov 28, 2022 - Use cautionDrug
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20
Exela Pharma Sciences recalls 50mL sodium bicarbonate vials due to reported breakage and glass flying when pressurized during administration preparation. Affected vials have specific lot numbers and expiration dates.
ExelaOct 4, 2022 - UnratedDrug
Exela Pharma Sciences LLC recalls 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 recalls 50mL sodium bicarbonate injection vials due to lack of sterility assurance. This medication is prescription-only and may pose infection risks if used.
ExelaJan 11, 2022 - Lower riskDrug
Exela Pharma Sciences LLC recalls Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma
Exela Pharma recalls Potassium Acetate Injection vials with short fill risk. Affected lots from April 2021 may have incorrect potassium levels. Contact for return instructions.
Exela PharmaMay 5, 2020 - Lower riskDrug
Exela Pharma Sciences LLC recalls Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by:
Exela Pharma Sciences recalls 75mg/0.2mg Diclo: tablets due to label mix-up with 50mg/0.2mg strength. No immediate danger but check your prescription bottles.
Exela Pharma SciencesApr 20, 2018
Exela Pharma Sciences LLC recall questions
How many recalls has Exela Pharma Sciences LLC had?
12 recalls from Exela Pharma Sciences LLC are on record with U.S. safety agencies, from 2018–2025.
What is the most recent Exela Pharma Sciences LLC recall?
Exela Pharma Sciences LLC recalls 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx, dated Jul 30, 2025. Every Exela Pharma Sciences LLC recall is listed on this page, newest first.
Why are Exela Pharma Sciences LLC products recalled?
The most common reasons on record: Presence of Particulate Matter: Silicone (3); Lack of Assurance of Sterility (2).
What should I do if I have a recalled Exela Pharma Sciences LLC product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Exela Pharma Sciences LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.