Strides Pharma Science Limited
FDA Regulatory Profile
Strides Pharma Science Limited has 1 FDA recall, 13 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-1029-2020 · Class III · Feb 17, 2020
- Latest inspection
- May 20, 2026 · VAI
Newer recall under related name Strides Pharma: Oct 7, 2026, D-0079-2027.
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | 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 | 13 | 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-1029-2020 | Class III | Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only… | Feb 17, 2020 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| May 20, 2026 | Bangalore, India | Drugs | Voluntary Action Indicated (VAI) | 3004554612 |
| Feb 24, 2023 | Puducherry, India | Drugs | Voluntary Action Indicated (VAI) | 3012448465 |
| Dec 9, 2022 | Bangalore, India | Drugs | Voluntary Action Indicated (VAI) | 3004554612 |
| Mar 5, 2020 | Bangalore, India | Drugs | No Action Indicated (NAI) | 3004554612 |
| Jan 17, 2020 | Bangalore, India | Drugs | Voluntary Action Indicated (VAI) | 3004554612 |
| May 24, 2019 | Bangalore, India | Drugs | Voluntary Action Indicated (VAI) | 3004554612 |
| Feb 5, 2019 | Puducherry, India | Drugs | Official Action Indicated (OAI) | 3012448465 |
| Nov 2, 2018 | Bangalore, India | Drugs | No Action Indicated (NAI) | 3004554612 |
| May 26, 2017 | Bangalore, India | Drugs | Voluntary Action Indicated (VAI) | 3004554612 |
| Feb 19, 2016 | Bangalore, India | Drugs | Voluntary Action Indicated (VAI) | 3004554612 |
| Aug 26, 2014 | Bangalore, India | Drugs | Voluntary Action Indicated (VAI) | 3004554612 |
| Dec 20, 2013 | Bangalore, India | Drugs | No Action Indicated (NAI) | 3004554612 |
| Jul 22, 2011 | Bangalore, India | Drugs | No Action Indicated (NAI) | 3004554612 |
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.