DrugOct 1, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate recall — FDA D-0672-2025
Failed Impurities/Degradation Specifications:
Class IIIFDA: OngoingGranules Pharmaceuticals Inc.
Recall history in this database
Classification mix: Class III: 5, Class II: 3.
DrugOct 1, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate recall — FDA D-0670-2025
Failed Impurities/Degradation Specifications:
Class IIIFDA: OngoingGranules Pharmaceuticals Inc.
DrugOct 1, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate recall — FDA D-0669-2025
Failed Impurities/Degradation Specifications:
Class IIIFDA: OngoingGranules Pharmaceuticals Inc.
DrugOct 1, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate recall — FDA D-0671-2025
Failed Impurities/Degradation Specifications:
Class IIIFDA: OngoingGranules Pharmaceuticals Inc.
DrugOct 1, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate recall — FDA D-0673-2025
Failed Impurities/Degradation Specifications:
Class IIIFDA: OngoingGranules Pharmaceuticals Inc.
DrugJul 9, 2025
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg recall — FDA D-0510-2025
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25C/60% RH) long-term.
Class IIFDA: OngoingGranules Pharmaceuticals Inc.
DrugJan 15, 2025
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles recall — FDA D-0192-2025
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 IIFDA: TerminatedGranules Pharmaceuticals Inc.
DrugAug 14, 2024
Gabapentin Tablets, USP, 600 mg, 500-count bottles recall — FDA D-0634-2024
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Class IIFDA: TerminatedGranules Pharmaceuticals Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Granules Pharmaceuticals Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.