Strides Pharma Inc.
Strides Pharma Inc. has 14 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0079-2027 · Class II · Oct 7, 2026
- Latest inspection
- Feb 16, 2024 · NAI
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Summary
| 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 | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|---|---|---|---|---|
| Strides Pharma Science Limited | 1 | 0 | 13 | 1 | Feb 17, 2020 (D-1029-2020) |
| Strides Pharma Private Limited | 0 | 0 | 7 | 0 | — |
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0079-2027 | Class II | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd… | Oct 7, 2026 |
| D-0390-2026 | Class II | Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured… | Mar 2, 2026 |
| D-0546-2025 | Class II | Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd… | Jul 9, 2025 |
| D-0294-2025 | Class II | Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides… | Mar 5, 2025 |
| D-0293-2025 | Class II | Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides… | Mar 5, 2025 |
| D-0260-2024 | Class II | Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science… | Dec 29, 2023 |
| D-0895-2023 | Class II | Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured… | Jun 26, 2023 |
| D-1330-2022 | Class II | Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science… | Jul 19, 2022 |
| D-0973-2022 | Class II | Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private… | May 18, 2022 |
| D-0974-2022 | Class II | Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private… | May 18, 2022 |
| D-0972-2022 | Class II | Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private… | May 18, 2022 |
| D-0006-2022 | Class II | Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured… | Sep 27, 2021 |
| D-0180-2021 | Class III | NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma… | Dec 22, 2020 |
| D-0858-2017 | Class III | Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited… | May 9, 2017 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 16, 2024 | East Brunswick, NJ | Drugs | No Action Indicated (NAI) | 3011707936 |
| Feb 8, 2022 | Chestnut Ridge, NY | Drugs | Voluntary Action Indicated (VAI) | 2434223 |
| Aug 23, 2019 | Chestnut Ridge, NY | Drugs | No Action Indicated (NAI) | 2434223 |
| Jun 5, 2019 | Chestnut Ridge, NY | Drugs | Voluntary Action Indicated (VAI) | 2434223 |
| Apr 18, 2018 | East Brunswick, NJ | Drugs | Voluntary Action Indicated (VAI) | 3011707936 |
| Mar 16, 2017 | Chestnut Ridge, NY | Drugs | Voluntary Action Indicated (VAI) | 2434223 |
| Jun 4, 2015 | Chestnut Ridge, NY | Drugs | Voluntary Action Indicated (VAI) | 2434223 |
| Feb 19, 2013 | Chestnut Ridge, NY | Drugs | Voluntary Action Indicated (VAI) | 2434223 |
| Apr 4, 2012 | Chestnut Ridge, NY | Drugs | No Action Indicated (NAI) | 2434223 |
| May 4, 2011 | Chestnut Ridge, NY | Drugs | No Action Indicated (NAI) | 2434223 |
| Aug 7, 2009 | Chestnut Ridge, NY | Drugs | Voluntary Action Indicated (VAI) | 2434223 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3011707936 | East Brunswick, NJ | 2 | Feb 16, 2024 |
| FEI 2434223 | Chestnut Ridge, NY | 9 | Feb 8, 2022 |