Granules Pharmaceuticals recalls
FDA enforcement reports naming Granules Pharmaceuticals Inc as the recalling firm.
- Recall reports
- 11
- Class I (serious)
- 0
- Most recent report
- Feb 11, 2026
- Feb 11, 2026Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granul…Drug · Granules Pharmaceuticals Inc.Presence of Foreign Tablets/CapsulesClass II
- Oct 1, 2025Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…Drug · Granules Pharmaceuticals Inc.Failed Impurities/Degradation Specifications:Class III
- Oct 1, 2025Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…Drug · Granules Pharmaceuticals Inc.Failed Impurities/Degradation Specifications:Class III
- Oct 1, 2025Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…Drug · Granules Pharmaceuticals Inc.Failed Impurities/Degradation Specifications:Class III
- Oct 1, 2025Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…Drug · Granules Pharmaceuticals Inc.Failed Impurities/Degradation Specifications:Class III
- Oct 1, 2025Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…Drug · Granules Pharmaceuticals Inc.Failed Impurities/Degradation Specifications:Class III
- Jul 9, 2025Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottleDrug · Granules Pharmaceuticals Inc.Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.Class II
- Jan 15, 2025Colchicine Capsules 0Drug · Granules Pharmaceuticals Inc.Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.Class II
- Jan 15, 2025Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx O…Drug · Granules Pharmaceuticals Inc.Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.Class II
- Aug 14, 2024Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules…Drug · Granules Pharmaceuticals Inc.Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin TabletsClass II
- Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct
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