Medications & Supplements/Prescription Drugs

Granules Colchicine Capsules Recalled for Failed Dissolution

Agency Publication Date: January 7, 2025

Summary

Granules Pharmaceuticals Inc. has recalled 96 bottles of Colchicine (colchicine) Capsules 0.6 mg because they failed dissolution testing. This means the medication may not dissolve properly in the body as intended. The recall involves 30-count bottles of the prescription medication from a specific production batch.

Risk

If the medication fails to dissolve correctly, the patient may not receive the full intended dose of the drug. This could result in ineffective treatment for medical conditions like gout flares.

What You Should Do

The recalled products are 30-count bottles of Colchicine Capsules 0.6 mg sold under the Granules Pharmaceuticals Inc. brand with NDC 70010-001-03.
Check the bottle label for lot number GPC240763B and an expiration date of 6/17/2026 to see if your medication is affected.
If you have health concerns about the effectiveness of your medication, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact Granules Pharmaceuticals Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Colchicine Capsules 0.6 mg (30-count bottle)

Variants: 0.6 mg, Capsule

Lot Numbers:

GPC240763B (Exp. 6/17/2026)

NDC:

70010-001-03

Rx only medication

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96026

Status: Resolved

Manufacturer: Granules Pharmaceuticals Inc.

Sold By: Retail Pharmacies

Manufactured In: United States

Units Affected: 96 Bottles

Distributed To: Nationwide

Agency Last Updated: May 16, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled products are 30-count bottles of Colchicine Capsules 0.6 mg sold under the Granules Pharmaceuticals Inc. brand with NDC 70010-001-03.

Check the bottle label for lot number GPC240763B and an expiration date of 6/17/2026 to see if your medication is affected.

If you have health concerns about the effectiveness of your medication, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact Granules Pharmaceuticals Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.