Teva Recalls Clonazepam Tablets Due to Content Uniformity Failure
Teva Pharmaceuticals is recalling specific lots of Clonazepam orally disintegrating tablets because they failed content uniformity specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling three boxes of Clonazepam Orally Disintegrating Tablets, USP, 0.5 mg. The affected product is identified by Lot # 32900136A and has an expiration date of 05/14. The NDC number for the recalled product is 0555-0096-96.
The recall is being conducted because the product failed to meet content uniformity specifications. This means the amount of active ingredient in the tablets may not be consistent with the required standards.
Consumers who have this specific lot of medication should contact their healthcare provider or pharmacist for guidance on what to do next.
The recalled product
- Product
- CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 3
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 # 32900136A
- Exp. 05/14
Distribution
Distributed in 1 state:
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