Granules Pharmaceuticals Inc.
FDA Regulatory Profile
Granules Pharmaceuticals Inc. has 11 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0305-2026 · Class II · Jan 26, 2026
- Latest inspection
- Apr 3, 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 | 11 | 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 | 6 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0305-2026 | Class II | Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India… | Jan 26, 2026 |
| D-0673-2025 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and… | Aug 28, 2025 |
| D-0669-2025 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and… | Aug 28, 2025 |
| D-0670-2025 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and… | Aug 28, 2025 |
| D-0672-2025 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and… | Aug 28, 2025 |
| D-0671-2025 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and… | Aug 28, 2025 |
| D-0510-2025 | Class II | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC… | Jun 24, 2025 |
| D-0192-2025 | Class II | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only… | Dec 30, 2024 |
| D-0187-2025 | Class II | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals… | Dec 18, 2024 |
| D-0634-2024 | Class II | Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited… | Jul 31, 2024 |
| D-1386-2020 | Class II | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01)… | Jul 3, 2020 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Apr 3, 2026 | Chantilly, VA | Drugs | Voluntary Action Indicated (VAI) | 3011585184 |
| Dec 15, 2023 | Chantilly, VA | Drugs | Voluntary Action Indicated (VAI) | 3011585184 |
| Aug 3, 2023 | Chantilly, VA | Drugs | No Action Indicated (NAI) | 3011585184 |
| Jul 22, 2022 | Chantilly, VA | Drugs | Voluntary Action Indicated (VAI) | 3011585184 |
| Aug 21, 2019 | Chantilly, VA | Drugs | Voluntary Action Indicated (VAI) | 3011585184 |
| Dec 8, 2017 | Chantilly, VA | Drugs | Voluntary Action Indicated (VAI) | 3011585184 |
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 3011585184 | Chantilly, VA | 6 | Apr 3, 2026 |