FDA Drugs recall ·
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only… recall
- Recall number
- D-0187-2025
- Date
- (initiated December 18, 2024)
- Company / brand
- Granules Pharmaceuticals Inc.
3701 Concorde Pkwy, Chantilly, VA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 96 Bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Why was it recalled?
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: GPC240763B, Exp. Date 6/17/2026
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0187-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.