FDA Drug recall D-0187-2025
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc
- FDA Drug
- Class II
- terminated
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc by Granules Pharmaceuticals, citing failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0187-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-12-18 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Granules Pharmaceuticals |
| Distribution | US |
Product
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Reason
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Identifiers
| ndc | 70010-001-01 |
|---|---|
| ndc | 70010-001-10 |
| ndc | 70010-001-03 |
| code_info | Lot#: GPC240763B, Exp. Date 6/17/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0187-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.