Colchicine Capsules 0 — Class II drug recall D-0187-2025
Terminated recall by Granules Pharmaceuticals Inc., reported 2025-01-15, distributed nationwide. Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions f
| Recall number | D-0187-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Granules Pharmaceuticals Inc., Chantilly, VA, United States |
| Recall initiated | 2024-12-18 |
| Classified | 2025-01-07 |
| Reported by FDA | 2025-01-15 |
| Terminated | 2025-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 96 bottles |
| Reason classes | specification failure |
| NDC | 70010-0001, 70010-0001-01, 70010-0001-03, 70010-0001-10 |
| Lot numbers | GPC240763B |
| Expiration dates | 2026-06-17 |
Product
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Reason for recall
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0187-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.