Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Colchicine Capsules 0.6 mg Recalled by Granules Pharmaceuticals Inc. Due to Failed Dissolution Specifications: Out of specification observed during...

Date: December 18, 2024
Company: Granules Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Granules Pharmaceuticals Inc. directly.

Affected Products

Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03

Quantity: 96 Bottles

Why Was This Recalled?

Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Granules Pharmaceuticals Inc.

Granules Pharmaceuticals Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report