Clonazepam Orally Disintegrating Tablets
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Yes — there is an active recall. 4 ongoing FDA recalls mention Clonazepam (15 total). Check the affected lots below.
Most common reason: Labeling / mix-up (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Clonazepam. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.
Labeling: Label Mixup: clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been mislabeled as the following drug: CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: ADWA00002136, EXP: 5/31/2014.
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
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