Drug FDA Class II Terminated Failed specifications

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

Granules Pharmaceuticals Inc. Published Jan 15, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Granules Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Failed Dissolution · primary

Affected products (1)

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

COLCHICINE · 96 Bottles

NDC: 70010-001, 70010-001-01, 70010-001-10, 70010-001-03

Code info: Lot#: GPC240763B, Exp. Date 6/17/2026

Affected areas

Nationwide

Timeline

Initiated

Dec 18, 2024
Published

Jan 15, 2025
Terminated

Jul 1, 2025

Recall number: D-0187-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.