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Granules Pharmaceuticals Inc. FDA Recalls
10 recalls on file across drugs, 0 of them Class I and 7 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 Class IIJan 26, 2026Presence of Foreign Tablets/Capsules |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, ExteClass IIIAug 28, 2025Failed Impurities/Degradation Specifications: |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, ExteClass IIIAug 28, 2025Failed Impurities/Degradation Specifications: |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, ExteClass IIIAug 28, 2025Failed Impurities/Degradation Specifications: |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, ExteClass IIIAug 28, 2025Failed Impurities/Degradation Specifications: |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, ExteClass IIIAug 28, 2025Failed Impurities/Degradation Specifications: |
| Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-couClass IIJun 24, 2025Failed Dissolution Specifications: Product failed to meet di |
| Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules InClass IIDec 30, 2024Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg t |
| Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 2015Class IIDec 18, 2024Failed Dissolution Specifications: Out of specification obse |
| Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, Class IIJul 31, 2024Presence of Foreign Tablets; 3 fused tablets of Metformin ER |