Granules Pharmaceuticals Inc.

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0305-2026Class IITrazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India LimiJanuary 26, 2026
D-0672-2025Class IIIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and AmpheAugust 28, 2025
D-0671-2025Class IIIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and AmpheAugust 28, 2025
D-0673-2025Class IIIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and AmpheAugust 28, 2025
D-0670-2025Class IIIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and AmpheAugust 28, 2025
D-0669-2025Class IIIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and AmpheAugust 28, 2025
D-0510-2025Class IIMetoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 7001June 24, 2025
D-0192-2025Class IIMetformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, ManufactDecember 30, 2024
D-0187-2025Class IIColchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals IncDecember 18, 2024
D-0634-2024Class IIGabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India LimitedJuly 31, 2024
D-1386-2020Class IIMetformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) aJuly 3, 2020