Class III · Low risk
Colchicine Tablets
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Colchicine Capsules 0.6 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Affected NDC
70010-0001-03
Compare with the code on your package — it is the most precise check available.
Drug: Colchicine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Colchicine NDC 70010-0001 |
.6 mg/1 | Capsule Oral |
Granules Pharmaceutical Inc. | Rx |
- Recalling firm
- Granules Pharmaceuticals Inc.
- NDC code
- 70010-001-03
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0187-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Colchicine recalls
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Class II · Moderate risk
Colcrys (colchicine, USP)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Colchicine 0.6 mg Caps
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Colchicine active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
COLCHICINE Tablet
Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37, EXP: 5/16/2014; PSEUDOEPHEDRINE HCL, Tablet, 30 mg, NDC 00904505360, Pedigree: AD52993_37, EXP: 5/20/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: AD62992_14, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904
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Failed Impurities/Degradation Specifications:
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