Colchicine Capsules 0.6 mg recall
FDA recall D-0187-2025 · initiated Dec 18, 2024
Granules Pharmaceuticals Inc. recalled Colchicine Capsules 0.6 mg in Dec 2024 — an FDA Class II recall (D-0187-2025) because Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 96 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
Frequently asked
- Was Colchicine Capsules 0.6 mg recalled?
- Granules Pharmaceuticals Inc. recalled Colchicine Capsules 0.6 mg in Dec 2024 — an FDA Class II recall (D-0187-2025) because Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Colchicine Capsules 0.6 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0187-2025 was: Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
- Is a recalled Colchicine Capsules 0.6 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Colchicine Capsules 0.6 mg are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot#: GPC240763B, Exp. Date 6/17/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0187-2025.