Granules Recalls Colchicine Capsules Due to Dissolution Failure
Granules Pharmaceuticals recalls 96 bottles of Colchicine Capsules 0.6 mg due to failed dissolution specifications. Check your lot number GPC240763B.
Use caution until it’s fixed
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Contact the company
What happened, in plain English
Granules Pharmaceuticals Inc. is recalling one lot of Colchicine Capsules 0.6 mg because the medication may not dissolve properly in the body. The recall affects 96 bottles distributed nationwide within the United States. This issue was identified during accelerated stability testing, which suggests the drug might not work as intended for patients. Read more at govinfonow.com/recall/32353-granules-recalls-colchicine-capsules-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/32353-granules-recalls-colchicine-capsules-due-to-dissolution-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-0187-2025
Cite this page
“Granules Recalls Colchicine Capsules Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32353-granules-recalls-colchicine-capsules-due-to-dissolution-failure. Based on FDA recall #D-0187-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0187-2025%22&limit=1).
Why it’s dangerous
The capsules failed to meet dissolution specifications under accelerated stability conditions. This means the drug might not release its active ingredient properly, potentially leading to reduced effectiveness in treating the condition it is prescribed for.
Who’s affected
Patients who have been prescribed Colchicine Capsules 0.6 mg and purchased them from pharmacies or distributors across the United States are affected. Individuals relying on this specific lot may receive a medication that does not dissolve correctly.
How to tell if you have this one
Check if you have Colchicine Capsules 0.6 mg in 30-count bottles manufactured by Granules Pharmaceuticals Inc. Look for NDC 70010-001-03 and Lot Number GPC240763B with an expiration date of 6/17/2026.
- Brand
Granules Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Medication
Verify if your bottle matches the recalled NDC 70010-001-03 and Lot Number GPC240763B.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to discuss alternatives or next steps since no specific remedy is listed in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0187-2025 (December 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0187-2025 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.