Class IITerminated

Colchicine Capsules 0.6 mg recall

FDA recall D-0187-2025 · initiated Dec 18, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Recalling company: Granules Pharmaceuticals Inc
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: Dec 18, 2024
FDA report date: Jan 15, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0187-2025 ↗

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