Shilpa Medicare Limited
FDA Regulatory Profile
Shilpa Medicare Limited has 8 FDA recalls, 10 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0764-2026 · Class II · Jul 29, 2026
- Latest inspection
- Oct 30, 2024 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 8 | 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 | 10 | 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-0764-2026 | Class II | PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only… | Jul 29, 2026 |
| D-0765-2026 | Class II | PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured… | Jul 29, 2026 |
| D-0125-2021 | Class II | Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare… | Dec 8, 2020 |
| D-0122-2021 | Class II | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One… | Dec 8, 2020 |
| D-0126-2021 | Class II | Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single… | Dec 8, 2020 |
| D-0123-2021 | Class II | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One… | Dec 8, 2020 |
| D-0121-2021 | Class II | Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use… | Dec 8, 2020 |
| D-0124-2021 | Class II | Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare… | Dec 8, 2020 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Oct 30, 2024 | Dabaspet, Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3018694237 |
| Mar 1, 2024 | Hyderbad, India | Drugs | No Action Indicated (NAI) | 3030542761 |
| Mar 10, 2023 | Hyderabad, India | Drugs | Voluntary Action Indicated (VAI) | 3019773458 |
| Feb 25, 2020 | Jadcherla, Mahabubnagar District, India | Drugs | Official Action Indicated (OAI) | 3009876430 |
| Sep 6, 2019 | Jadcherla, Mahabubnagar District, India | Drugs | Voluntary Action Indicated (VAI) | 3009876430 |
| Feb 13, 2019 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3010619401 |
| Nov 30, 2017 | Jadcherla, Mahabubnagar District, India | Drugs | Voluntary Action Indicated (VAI) | 3009876430 |
| Jul 28, 2017 | Jadcherla, Mahabubnagar District, India | Drugs | No Action Indicated (NAI) | 3009876430 |
| Jul 26, 2016 | Jadcherla, Mahabubnagar District, India | Drugs | No Action Indicated (NAI) | 3009876430 |
| Aug 26, 2015 | Jadcherla, Mahabubnagar District, India | Drugs | Voluntary Action Indicated (VAI) | 3009876430 |
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 3018694237 | Dabaspet, Bengaluru, India | 1 | Oct 30, 2024 |
| FEI 3030542761 | Hyderbad, India | 1 | Mar 1, 2024 |
| FEI 3019773458 | Hyderabad, India | 1 | Mar 10, 2023 |
| FEI 3009876430 | Jadcherla, Mahabubnagar District, India | 6 | Feb 25, 2020 |
| FEI 3010619401 | Bengaluru, India | 1 | Feb 13, 2019 |