Clozapine Tablets (Teva Pharmaceuticals) – Disintegration Failure (2018)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
Brand
Teva Pharmaceuticals USA
Lot Codes / Batch Numbers
Lot #: 34034024B, Exp 02/20
Products Sold
Lot #: 34034024B, Exp 02/20
Teva Pharmaceuticals USA is recalling Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals U due to Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026