Losartan 50mg Tablet — Class II drug recall D-1081-2019
Terminated recall by RemedyRepack Inc., reported 2019-04-17, distributed in FL. CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingred
| Recall number | D-1081-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2019-03-14 |
| Classified | 2019-04-05 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2019-04-11 |
| Distributed | FL |
| Reason classes | cgmp, specification failure |
| NDC | 70518-0588-01 |
| Lot numbers | J0328416-101518 |
| Expiration dates | 2019-10 |
Product
Losartan 50mg Tablet, 30 count each blister card.
Reason for recall
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
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-1081-2019. 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.