InvaGen Pharmaceuticals, Inc.
FDA Regulatory Profile
InvaGen Pharmaceuticals, Inc. has 11 FDA recalls (1 Class I), 21 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0220-2024 · Class I · Nov 17, 2023
- Latest inspection
- Jul 17, 2026 · VAI
Newer recall under related name Cipla Usa: Sep 18, 2026, D-0014-2027.
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 11 (1 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 | 21 | 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 |
|---|
Cipla Usa
Same company group | 24 | 0 | 0 | 0 | Sep 18, 2026 (D-0014-2027) |
Cipla Limited
Same company group | 3 | 0 | 35 | 2 | Oct 31, 2025 (D-0197-2026) |
Cipla
Same company group | 11 | 0 | 11 | 0 | Sep 29, 2022 (D-1550-2022) |
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0220-2024 | Class I | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by… | Nov 17, 2023 |
| D-1272-2020 | Class III | Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals… | May 14, 2020 |
| D-1454-2019 | Class III | Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5… | Jun 12, 2019 |
| D-1125-2019 | Class II | Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL… | Mar 22, 2019 |
| D-1124-2019 | Class II | Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only… | Mar 22, 2019 |
| D-1123-2019 | Class II | Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL… | Mar 22, 2019 |
| D-0012-2019 | Class III | Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd… | Oct 3, 2018 |
| D-1212-2018 | Class III | Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05)… | Sep 6, 2018 |
| D-0619-2018 | Class III | buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b)… | Mar 15, 2018 |
| D-0618-2018 | Class III | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured… | Mar 15, 2018 |
| D-0698-2018 | Class III | Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India… | Mar 5, 2018 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 17, 2026 | Central Islip, NY | Drugs | Voluntary Action Indicated (VAI) | 3012696190 |
| Oct 25, 2023 | Hauppauge, NY | Drugs | No Action Indicated (NAI) | 3003950641 |
| Sep 19, 2023 | Central Islip, NY | Drugs | Voluntary Action Indicated (VAI) | 3012696190 |
| May 1, 2023 | Fall River, MA | Drugs | No Action Indicated (NAI) | 3017588287 |
| Dec 6, 2019 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
| Dec 19, 2018 | Central Islip, NY | Drugs | Voluntary Action Indicated (VAI) | 3012696190 |
| May 25, 2018 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
| May 26, 2017 | Central Islip, NY | Drugs | Voluntary Action Indicated (VAI) | 3012696190 |
| Mar 30, 2017 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
| Apr 20, 2016 | Hauppauge, NY | Drugs | No Action Indicated (NAI) | 3003950641 |
| May 26, 2015 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
| Mar 13, 2015 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
| Mar 8, 2013 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
| Jun 14, 2012 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
| Mar 2, 2012 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
| Aug 12, 2011 | Hauppauge, NY | Drugs | No Action Indicated (NAI) | 3003950641 |
| Apr 13, 2011 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
| Nov 10, 2010 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
| Aug 27, 2010 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
| Feb 19, 2010 | Hauppauge, NY | Drugs | Voluntary Action Indicated (VAI) | 3003950641 |
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.