Alembic Pharmaceuticals Limited
FDA Regulatory Profile
Alembic Pharmaceuticals Limited has 9 FDA recalls (1 Class I), 30 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0248-2026 · Class III · Dec 16, 2025
- Latest inspection
- Feb 18, 2026 · 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 | 9 (1 Class I) | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 30 | Nov 11, 2026 | Newest record Nov 5, 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 |
|---|
Alembic
Same company group | 0 | 13 | 0 | 0 | — |
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0248-2026 | Class III | Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic… | Dec 16, 2025 |
| D-0156-2026 | Class III | Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by… | Oct 10, 2025 |
| D-0566-2025 | Class II | Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic… | Jul 25, 2025 |
| D-0459-2025 | Class II | Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals… | May 9, 2025 |
| D-0447-2025 | Class II | Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic… | May 7, 2025 |
| D-1086-2023 | Class III | Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic… | Jul 27, 2023 |
| D-0941-2023 | Class II | Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only… | Jun 22, 2023 |
| D-0326-2021 | Class I | Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals… | Mar 17, 2021 |
| D-1341-2020 | Class II | Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic… | Jun 10, 2020 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Feb 18, 2026 | Vadodara, India | Drugs | Voluntary Action Indicated (VAI) | 3015685305 |
| May 31, 2025 | Panchmahal, India | Drugs | Voluntary Action Indicated (VAI) | 3003821360 |
| Mar 21, 2025 | Vadodara, India | Drugs | No Action Indicated (NAI) | 3007501748 |
| Nov 22, 2024 | Vadodara, India | Drugs | Voluntary Action Indicated (VAI) | 3016088083 |
| Oct 8, 2024 | Panchmahal, India | Drugs | No Action Indicated (NAI) | 3003821360 |
| Jul 26, 2024 | Panchmahal, India | Drugs | No Action Indicated (NAI) | 3004956904 |
| Mar 8, 2024 | Panchmahal, India | Drugs | Voluntary Action Indicated (VAI) | 3014866088 |
| Mar 24, 2023 | Vadodara, India | Drugs | Voluntary Action Indicated (VAI) | 3015685305 |
| Mar 10, 2023 | Vadodara, India | Drugs | No Action Indicated (NAI) | 3013826490 |
| Oct 21, 2022 | Vadodara, India | Drugs | No Action Indicated (NAI) | 3003238213 |
| Mar 13, 2020 | Panchmahal, India | Drugs | Voluntary Action Indicated (VAI) | 3004956904 |
| Jan 8, 2020 | Vadodara, India | Drugs | No Action Indicated (NAI) | 3013826490 |
| Aug 20, 2019 | Vadodara, India | Drugs | No Action Indicated (NAI) | 3003238213 |
| Oct 26, 2018 | Panchmahal, India | Drugs | No Action Indicated (NAI) | 3004956904 |
| May 18, 2018 | Vadodara, India | Drugs | Voluntary Action Indicated (VAI) | 3007501748 |
| Apr 23, 2018 | Panchmahal, India | Drugs | No Action Indicated (NAI) | 3003821360 |
| Mar 20, 2018 | Panchmahal, India | Drugs | Voluntary Action Indicated (VAI) | 3004956904 |
| Apr 12, 2017 | Vadodara, India | Drugs | No Action Indicated (NAI) | 3003238213 |
| Jun 29, 2016 | Panchmahal, India | Drugs | No Action Indicated (NAI) | 3003821360 |
| Mar 25, 2016 | Panchmahal, India | Drugs | Voluntary Action Indicated (VAI) | 3004956904 |
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 3015685305 | Vadodara, India | 2 | Feb 18, 2026 |
| FEI 3003821360 | Panchmahal, India | 8 | May 31, 2025 |
| FEI 3007501748 | Vadodara, India | 5 | Mar 21, 2025 |
| FEI 3016088083 | Vadodara, India | 1 | Nov 22, 2024 |
| FEI 3004956904 | Panchmahal, India | 8 | Jul 26, 2024 |
| FEI 3014866088 | Panchmahal, India | 1 | Mar 8, 2024 |
| FEI 3013826490 | Vadodara, India | 2 | Mar 10, 2023 |
| FEI 3003238213 | Vadodara, India | 3 | Oct 21, 2022 |