Clonazepam Orally Disintegrating Tablets Carton Mislabeled on Declared Strength
Endo USA recalls 8,029 cartons of Clonazepam 0.125 mg tablets nationwide due to incorrect carton labeling, although the tablets in the blister strips have the correct strength.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which indicates a reasonable probability of serious adverse health consequences. The labeling error involves a benzodiazepine medication where dosing accuracy is critical.
Plain-English summary
Endo USA, Inc. is recalling 8,029 cartons of Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, distributed nationwide. The product is supplied as a benzodiazepine medication in packages of 60 tablets (10 blister cards containing 6 tablets each). The affected lot is Lot #550174101 with an expiration date of January 31, 2027.
The recall was initiated due to a labeling error on the carton. Some cartons were labeled with an incorrect declared strength. However, the blister strips contained inside each carton show the correct strength.
This recall affects consumers, healthcare providers, and pharmacies who may have received the affected cartons nationwide. The FDA classified this as a Class I recall due to the potential for dosing confusion regarding medication strength on a controlled benzodiazepine medication.
Consumers and healthcare providers who have this product should verify the strength on the individual blister strips rather than relying on the carton label. Contact a healthcare provider or pharmacist with any questions regarding the affected medication.
The recalled product
- Product
- CLONAZEPAM (CLONAZEPAM)
- Brand
- CLONAZEPAM
- Manufacturer
- Endo USA, Inc.
- Category
- Drug
- Hazard
- Affected units
- 8,029
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 #: 550174101
- Exp. 01/31/2027.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Endo USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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