AuroMedics Pharma LLC
AuroMedics Pharma LLC has 36 FDA recalls (9 Class I), 0 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0020-2023 · Class II · Sep 30, 2022
Newer recall under related name Aurobindo Pharma Usa: Jul 23, 2026, D-0733-2026.
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 36 (9 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 | 0 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|---|---|---|---|---|
| Aurobindo Pharma Usa | 59 | 0 | 5 | 0 | Jul 23, 2026 (D-0733-2026) |
| Aurolife Pharma | 14 | 0 | 11 | 1 | May 18, 2023 (D-0877-2023) |
| Aurobindo Pharma | 3 | 0 | 12 | 0 | Feb 2, 2018 (D-0427-2018) |
| Aurobindo Pharma Limited | 0 | 0 | 20 | 1 | — |
| Eugia Pharma Specialities Limited | 0 | 0 | 15 | 2 | — |
| Apl Healthcare Limited | 0 | 0 | 7 | 0 | — |
| Acrotech Biopharma | 0 | 0 | 2 | 0 | — |
| Auro Packaging | 0 | 0 | 2 | 0 | — |
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0020-2023 | Class II | Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed… | Sep 30, 2022 |
| D-0013-2023 | Class II | Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by… | Sep 26, 2022 |
| D-1551-2022 | Class III | Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only… | Sep 26, 2022 |
| D-0556-2022 | Class I | Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton… | Jan 26, 2022 |
| D-0248-2021 | Class II | Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use… | Dec 30, 2020 |
| D-0853-2020 | Class III | Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For… | Feb 7, 2020 |
| D-0852-2020 | Class II | Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by… | Feb 7, 2020 |
| D-0789-2020 | Class III | Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use… | Dec 2, 2019 |
| D-0574-2020 | Class II | Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton… | Nov 25, 2019 |
| D-0636-2020 | Class I | Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA… | Nov 20, 2019 |
| D-0637-2020 | Class I | Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA… | Nov 20, 2019 |
| D-0653-2020 | Class II | Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ… | Nov 19, 2019 |
| D-0609-2020 | Class II | Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC… | Nov 12, 2019 |
| D-0521-2020 | Class III | Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx… | Nov 11, 2019 |
| D-0573-2020 | Class II | Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL… | Nov 11, 2019 |
| D-0520-2020 | Class III | Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx… | Nov 11, 2019 |
| D-0522-2020 | Class III | Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx… | Nov 11, 2019 |
| D-0528-2020 | Class II | Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA… | Nov 6, 2019 |
| D-0529-2020 | Class II | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only… | Nov 6, 2019 |
| D-0526-2020 | Class II | DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100… | Nov 6, 2019 |