Teva Recalls Clozapine Tablets Due to Failed Disintegration Testing
Teva Pharmaceuticals is recalling 313 bottles of Clozapine 12.5 mg tablets because routine stability testing showed the tablets failed to disintegrate as required.
What this means for you
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, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a failure to meet disintegration specifications, which is a quality control issue rather than a direct contamination or acute safety hazard like a foreign object or toxic substance.
Plain-English summary
Teva Pharmaceuticals USA is recalling 313 bottles of Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles. The affected product is identified by Lot # 34034024B and has an expiration date of 02/20. The tablets are yellow, round, flat-faced, beveled-edge, unscored, and debossed with 13 on one side.
The recall was initiated because an out-of-specification disintegration test result was obtained during routine stability testing. This means the tablets did not meet the required standards for breaking apart in the body as intended.
The affected product was distributed nationwide in the USA. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- CLOZAPINE (CLOZAPINE)
- Brand
- CLOZAPINE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 313
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 #: 34034024B
- Exp 02/20
Distribution
Distributed nationwide across the United States.
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