Granules Pharmaceuticals Inc.
Complete recall history across all FDA and CPSC categories — 10 total recalls
Granules Pharmaceuticals Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (10)
FDA drug safety enforcement actions by Granules Pharmaceuticals Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 26, 2026 | Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured ... | Presence of Foreign Tablets/Capsules | Class II |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III |
| Jun 24, 2025 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100... | Failed Dissolution Specifications: Product failed to meet dissolution accepta... | Class II |
| Dec 30, 2024 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bot... | Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found i... | Class II |
| Dec 18, 2024 | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granu... | Failed Dissolution Specifications: Out of specification observed during the a... | Class II |
| Jul 31, 2024 | Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by:... | Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were foun... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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