Clonazepam Orally Disintegrating Tablets USP — Class II drug recall D-0082-2019
Terminated recall by Teva Pharmaceuticals USA, reported 2018-10-24, distributed nationwide. Failed Stability Specifications: Out-of-specification test result for water content obtained during routine st
| Recall number | D-0082-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2018-09-20 |
| Classified | 2018-10-18 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2019-11-07 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00555-0098-96 |
| Lot numbers | 34033752A |
| Expiration dates | 2020-01 |
Product
Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
Reason for recall
Failed Stability Specifications: Out-of-specification test result for water content 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-0082-2019. 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.