NATCO Pharma Limited
FDA Regulatory Profile
NATCO Pharma Limited has 2 FDA recalls, 18 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0438-2024 · Class II · Mar 27, 2024
- Latest inspection
- Nov 21, 2025 · 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 | 2 | 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 | 18 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0438-2024 | Class II | Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn… | Mar 27, 2024 |
| D-0318-2024 | Class II | Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma… | Feb 1, 2024 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Nov 21, 2025 | Chennai, India | Drugs | Voluntary Action Indicated (VAI) | 3009870595 |
| Jun 19, 2025 | Rangareddy, India | Drugs | Voluntary Action Indicated (VAI) | 3004540906 |
| Jun 13, 2025 | Rangareddy, India | Drugs | Voluntary Action Indicated (VAI) | 3004065860 |
| Nov 1, 2023 | Hyderabad, India | Drugs | No Action Indicated (NAI) | 3017064484 |
| Feb 3, 2023 | Anakapalli, India | Drugs | Voluntary Action Indicated (VAI) | 3015380536 |
| Aug 9, 2019 | Rangareddy, India | Drugs | Voluntary Action Indicated (VAI) | 3004065860 |
| Jul 12, 2019 | Chennai, India | Drugs | No Action Indicated (NAI) | 3009870595 |
| Jun 24, 2019 | Rangareddy, India | Drugs | Voluntary Action Indicated (VAI) | 3004540906 |
| Jun 6, 2019 | Rangareddy, India | Drugs | Voluntary Action Indicated (VAI) | 3004540906 |
| Feb 16, 2018 | Rangareddy, India | Drugs | No Action Indicated (NAI) | 3004065860 |
| Oct 6, 2017 | Rangareddy, India | Drugs | Voluntary Action Indicated (VAI) | 3007101795 |
| Jan 24, 2017 | Rangareddy, India | Drugs | Voluntary Action Indicated (VAI) | 3004540906 |
| Feb 12, 2016 | Chennai, India | Drugs | Voluntary Action Indicated (VAI) | 3009870595 |
| Oct 13, 2014 | Rangareddy, India | Drugs | Voluntary Action Indicated (VAI) | 3004065860 |
| May 23, 2014 | Rangareddy, India | Drugs | Voluntary Action Indicated (VAI) | 3004540906 |
| Nov 24, 2011 | Rangareddy, India | Drugs | Voluntary Action Indicated (VAI) | 3004065860 |
| Nov 18, 2011 | Rangareddy, India | Drugs | No Action Indicated (NAI) | 3004540906 |
| Feb 12, 2009 | Rangareddy, India | Drugs | Voluntary Action Indicated (VAI) | 3004540906 |
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 3009870595 | Chennai, India | 3 | Nov 21, 2025 |
| FEI 3004540906 | Rangareddy, India | 7 | Jun 19, 2025 |
| FEI 3004065860 | Rangareddy, India | 5 | Jun 13, 2025 |
| FEI 3017064484 | Hyderabad, India | 1 | Nov 1, 2023 |
| FEI 3015380536 | Anakapalli, India | 1 | Feb 3, 2023 |
| FEI 3007101795 | Rangareddy, India | 1 | Oct 6, 2017 |