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D-0187-2025Class II

Granules Pharmaceuticals Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Granules Pharmaceuticals Inc.
Product type
Drug
Status
Terminated
Report date
2025-01-15
Distribution
Nationwide within the United States
Firm state
VA
Product quantity
96 Bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →