Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Clozapine Orally Disintegrating Tablets Recalled by Teva Pharmaceuticals USA Due to Failed Disintegration Specifications: Out-of-specification disintegration test result obtained...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Teva Pharmaceuticals USA directly.
Affected Products
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.
Quantity: 313 bottles
Why Was This Recalled?
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Teva Pharmaceuticals USA
Teva Pharmaceuticals USA has 196 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report