Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot#: GPC240763B, Exp. Date 6/17/2026
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0187-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 18, 2024
- FDA report date
- Jan 15, 2025
- Quantity
- 96 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Granules Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0187-2025, exactly as published.
Show all FDA fields
- City
- Chantilly
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 96026
- Address
- 3701 Concorde Pkwy
- Code information
- Lot#: GPC240763B, Exp. Date 6/17/2026
- Postal code
- 20151-1126
- Report date
- Jan 15, 2025
- Product type
- Drugs
- Recall number
- D-0187-2025
- Classification
- Class II
- Recalling firm
- Granules Pharmaceuticals Inc.
- Product quantity
- 96 Bottles
- Termination date
- Jul 1, 2025
- Reason for recall
- Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 7, 2025