Aurolife Pharma, LLC
FDA Regulatory Profile
Aurolife Pharma, LLC has 14 FDA recalls, 11 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0877-2023 · Class III · May 18, 2023
- Latest inspection
- Aug 26, 2022 · VAI
Newer recall under related name Aurobindo Pharma Usa: Jul 23, 2026, D-0733-2026.
Reviewing Aurolife Pharma, 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 Aurolife Pharma, 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 | 14 | 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 | 11 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0877-2023 | Class III | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA… | May 18, 2023 |
| D-0087-2023 | Class II | Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc… | Dec 16, 2022 |
| D-0736-2022 | Class II | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA… | Mar 17, 2022 |
| D-1870-2019 | Class II | Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1)… | Aug 23, 2019 |
| D-1874-2019 | Class II | Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD… | Aug 23, 2019 |
| D-1873-2019 | Class II | Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen… | Aug 23, 2019 |
| D-1866-2019 | Class II | Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor… | Aug 23, 2019 |
| D-1865-2019 | Class II | Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons… | Aug 23, 2019 |
| D-1864-2019 | Class II | Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC… | Aug 23, 2019 |
| D-1867-2019 | Class II | fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by… | Aug 23, 2019 |
| D-1871-2019 | Class II | Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572… | Aug 23, 2019 |
| D-1868-2019 | Class II | Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2)… | Aug 23, 2019 |
| D-1872-2019 | Class II | Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by… | Aug 23, 2019 |
| D-1869-2019 | Class II | Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by… | Aug 23, 2019 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 26, 2022 | Durham, NC | Drugs | Voluntary Action Indicated (VAI) | 3014028588 |
| Dec 7, 2021 | Dayton, NJ | Drugs | Official Action Indicated (OAI) | 3005796917 |
| Oct 22, 2019 | Dayton, NJ | Drugs | Voluntary Action Indicated (VAI) | 3005796917 |
| Jun 14, 2018 | Dayton, NJ | Drugs | Voluntary Action Indicated (VAI) | 3005796917 |
| Jul 28, 2016 | Dayton, NJ | Drugs | No Action Indicated (NAI) | 3005796917 |
| Jan 12, 2016 | Dayton, NJ | Drugs | No Action Indicated (NAI) | 3005796917 |
| Jul 9, 2015 | Dayton, NJ | Drugs | No Action Indicated (NAI) | 3005796917 |
| Oct 15, 2013 | Dayton, NJ | Drugs | Voluntary Action Indicated (VAI) | 3005796917 |
| Nov 2, 2011 | Dayton, NJ | Drugs | Voluntary Action Indicated (VAI) | 3005796917 |
| May 25, 2011 | Dayton, NJ | Drugs | Voluntary Action Indicated (VAI) | 3005796917 |
| May 11, 2009 | Dayton, NJ | Drugs | No Action Indicated (NAI) | 3005796917 |
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.