Granules Pharmaceuticals Inc.
Granules Pharmaceuticals Inc. appears in FDA public data with 11 recalls, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0305-2026, Class II) was initiated on January 26, 2026.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
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 Limi | January 26, 2026 |
| D-0671-2025 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | August 28, 2025 |
| D-0669-2025 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | August 28, 2025 |
| D-0670-2025 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | August 28, 2025 |
| D-0672-2025 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | August 28, 2025 |
| D-0673-2025 | Class III | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | August 28, 2025 |
| D-0510-2025 | Class II | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 7001 | June 24, 2025 |
| D-0192-2025 | Class II | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufact | December 30, 2024 |
| D-0187-2025 | Class II | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc | December 18, 2024 |
| D-0634-2024 | Class II | Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited | July 31, 2024 |
| D-1386-2020 | Class II | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) a | July 3, 2020 |