Colchicine Capsules Recalled Due to Failed Dissolution Specifications
Granules Pharmaceuticals is recalling Colchicine 0.6 mg capsules nationwide due to failed dissolution specifications detected during stability testing. Patients should contact their healthcare provider for guidance.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a manufacturing quality issue (failed dissolution specifications) detected during stability testing, representing a theoretical risk to drug efficacy. Per the rubric, recalls with theoretical risks and no reported harm score at most 3 (High).
Plain-English summary
Granules Pharmaceuticals Inc. is recalling Colchicine 0.6 mg capsules nationwide due to failed dissolution specifications observed during accelerated stability testing. The recall affects 96 bottles of the 30-count formulation with lot number GPC240763B, expiring June 17, 2026.
The capsules failed to meet dissolution specifications during accelerated stability testing, meaning the medication may not dissolve properly in the body as intended. This could affect how the drug is absorbed and its therapeutic effectiveness.
The affected product was distributed nationwide. Patients who have received this medication should contact their healthcare provider or pharmacist for guidance regarding their treatment.
Consumers with the recalled lot should contact their pharmacy or healthcare provider. Do not discontinue use of this medication without consulting your healthcare provider, as they will need to arrange alternative medication to ensure continued treatment.
The recalled product
- Product
- COLCHICINE (COLCHICINE)
- Brand
- COLCHICINE
- Manufacturer
- Granules Pharmaceuticals Inc.
- Category
- Drug
- Affected units
- 96
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: GPC240763B
- Exp. Date 6/17/2026
UPCs (1)
- 0370010001039
Distribution
Distributed nationwide across the United States.
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