Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Clonazepam recalled?

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.

Clonazepam recalls on record

none so far in 2026; 15 on record, newest first
Class I · High risk

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.

Ongoing Labeling / mix-up Endo USA, Inc. D-0181-2025
Class I · High risk

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.

Ongoing Labeling / mix-up Endo USA, Inc. D-0180-2025
Class I · High risk

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.

Ongoing Labeling / mix-up Endo USA, Inc. D-0179-2025
Class I · High risk

Clonazepam Orally Disintegrating Tablet

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

Ongoing Labeling / mix-up Endo USA, Inc. D-0178-2025
Class I · High risk

Clonazepam Orally Disintegrating Tablets

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.

Terminated Labeling / mix-up Endo Pharmaceuticals, Inc. NDC 49884-306-02 D-0622-2024
Class III · Low risk

Clonazepam Orally Disintegrating Tablets

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

Terminated Cross-contamination Sun Pharmaceutical Industries INC NDC 57664-783-86 D-1445-2020
Class III · Low risk

Klonopin (clonazepam)

Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.

Terminated Labeling / mix-up Genentech, Inc. NDC 0004-0068-01 D-0416-2018
Class III · Low risk

Clonazepam Tablets

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.

Terminated Impurity / degradation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-882-20 D-0136-2017
Class III · Low risk

Clonazepam Tablets

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.

Terminated Impurity / degradation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-881-20 D-0135-2017
Class III · Low risk

Clonazepam Tablets

Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.

Terminated Impurity / degradation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) D-0650-2016
Class II · Moderate risk

Clonazepam Tablets

Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.

Terminated Wrong potency / content Actavis Elizabeth LLC NDC 0228-3005-11 D-1087-2014
Class II · Moderate risk

clonazePAM

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.

Terminated Labeling / mix-up Aidapak Services, LLC D-830-2014