December 2024 FDA Recall Colchicine by Granules Pharmaceuticals Inc.
D-0187-2025 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Granules Pharmaceuticals Inc. on December 18, 2024 for the product Colchicine. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0187-2025
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
12-18-2024
01-15-2025
96 Bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Granules Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
07-01-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Batch or Lot Expiration Information
Lot# : GPC240763B, Exp. Date 6/17/2026
