Recall: D-0187-2025

Class II - Potentially Harmful

Class IIClassification

2024-12-18Initiated

TerminatedStatus

Granules Pharmaceuticals Inc.Firm

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.

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.