Clozapine Orally Disintegrating Tablets — Class II drug recall D-0001-2019
Terminated recall by Teva Pharmaceuticals USA, reported 2018-10-10, distributed nationwide. Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine
| Recall number | D-0001-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2018-09-21 |
| Classified | 2018-10-01 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2019-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 313 bottles |
| Reason classes | specification failure |
| NDC | 00093-5376, 00093-5376-01, 00093-5376-19, 00093-5376-84, 00093-5377, 00093-5377-01, 00093-5377-19, 00093-5377-84, 00093-5416, 00093-5416-01, 00093-5417, 00093-5417-01, 00093-5417-19, 00093-5417-84, 00093-5419, 00093-5419-01, 00093-5419-19, 00093-5419-84 |
| Lot numbers | 02/20, 34034024B |
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.
Reason for recall
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0001-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.