Olmesartan Medoxomil and Hydrochlorothiazide Tablets — Class II drug recall D-0381-2019
Terminated recall by Teva Pharmaceuticals USA, reported 2019-01-23, distributed nationwide. Failed dissolution specifications
| Recall number | D-0381-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2018-12-19 |
| Classified | 2019-01-16 |
| Reported by FDA | 2019-01-23 |
| Terminated | 2020-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 181,456 bottles |
| Reason classes | specification failure |
| NDC | 00093-7617-56, 00093-7617-98 |
| Expiration dates | 2019-02 |
Product
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454
Reason for recall
Failed dissolution specifications
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-0381-2019. 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.