CLASS II Drug recall · Reported 15 Jan 2025 · FDA Enforcement Report
Colchicine Capsules 0.6 mg recalled by Granules Pharmaceuticals
Granules Pharmaceuticals is recalling Colchicine Capsules 0.6 mg, distributed nationwide in the US. The recall was initiated on 18 Dec 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0187-2025
- FDA event ID
- 96026
- Recalling firm
- Granules Pharmaceuticals, Chantilly, VA
- Brand
- Colchicine
- Manufacturer
- Granules Pharmaceutical Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2024
- FDA classified
- 7 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 18 Dec 2024 | Recall initiated by company | |
| 7 Jan 2025 | Classified by FDA | +20 days |
| 15 Jan 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Which lots are affected?
Lot#: GPC240763B, Exp. Date 6/17/2026
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Granules Pharmaceuticals
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Trazodone Hydrochloride, USP, 50 mg recalled by Granules PharmaceuticalsTrazodone Hydrochloride | Granules Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
Other Colchicine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Colchicine Tablets, USP 0.6 mg recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | AZ, MS, OH |
| Drug | CLASS II | Colchicine Tablet, 0.6 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |