Drug recall
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc…
FDA recall event 96026 · Class II · Granules Pharmaceuticals Inc.
Key facts
| Event ID | 96026 |
|---|---|
| Recall numbers | D-0187-2025 |
| Recalling firm | Granules Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. |
| Initiation date | Dec 18, 2024 |
| Report date | Jan 15, 2025 |
| Termination date | Jul 1, 2025 |
| City | Chantilly |
| State | VA |
| Country | United States |
| FEI number | 3011585184 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: