Exela Pharma Sciences LLC
FDA Regulatory Profile
Exela Pharma Sciences LLC has 12 FDA recalls (7 Class I), 12 inspections, 0 510(k) clearances and 3 compliance actions on record.
- Latest recall
- D-0620-2025 · Class II · Jul 30, 2025
- Latest inspection
- Nov 15, 2024 · OAI
Reviewing Exela Pharma Sciences LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Check this supplier
Or check Exela Pharma Sciences LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 12 (7 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 12 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 3 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0620-2025 | Class II | 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL… | Jul 30, 2025 |
| D-0303-2025 | Class II | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per… | Mar 7, 2025 |
| D-0117-2024 | Class I | Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25… | Oct 18, 2023 |
| D-0118-2024 | Class I | ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile… | Oct 18, 2023 |
| D-0116-2024 | Class I | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial… | Oct 18, 2023 |
| D-0079-2023 | Class I | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in… | Nov 28, 2022 |
| D-0080-2023 | Class I | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in… | Nov 28, 2022 |
| D-0022-2023 | Class I | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in… | Oct 4, 2022 |
| D-0023-2023 | Class I | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in… | Oct 4, 2022 |
| D-0369-2022 | Class II | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured… | Jan 11, 2022 |
| D-1585-2020 | Class III | Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured… | May 5, 2020 |
| D-0826-2018 | Class II | Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only… | Apr 20, 2018 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Nov 15, 2024 | Lenoir, NC | Drugs | Official Action Indicated (OAI) | 3008563008 |
| Jul 18, 2019 | Lenoir, NC | Drugs | Voluntary Action Indicated (VAI) | 3008563008 |
| Dec 19, 2018 | Lenoir, NC | Drugs | No Action Indicated (NAI) | 3008563008 |
| Sep 11, 2018 | Lenoir, NC | Drugs | No Action Indicated (NAI) | 3008563008 |
| Sep 28, 2017 | Lenoir, NC | Drugs | Voluntary Action Indicated (VAI) | 3008563008 |
| Jun 8, 2016 | Lenoir, NC | Drugs | No Action Indicated (NAI) | 3008563008 |
| Nov 21, 2014 | Lenoir, NC | Drugs | Voluntary Action Indicated (VAI) | 3008563008 |
| Aug 28, 2014 | Lenoir, NC | Drugs | No Action Indicated (NAI) | 3008563008 |
| Apr 12, 2013 | Lenoir, NC | Drugs | No Action Indicated (NAI) | 3008563008 |
| Jan 20, 2012 | Lenoir, NC | Drugs | No Action Indicated (NAI) | 3008563008 |
| Sep 2, 2011 | Lenoir, NC | Drugs | Voluntary Action Indicated (VAI) | 3008563008 |
| Dec 10, 2010 | Lenoir, NC | Drugs | Voluntary Action Indicated (VAI) | 3008563008 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3008563008 | Lenoir, NC | 12 | Nov 15, 2024 |