Losartan Potassium Tablets — Class II drug recall D-1075-2019
Terminated recall by Legacy Pharmaceutical Packaging LLC, reported 2019-04-10, distributed in AZ, IN, TN. CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
| Recall number | D-1075-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Legacy Pharmaceutical Packaging LLC, Earth City, MO, United States |
| Recall initiated | 2019-03-01 |
| Classified | 2019-04-01 |
| Reported by FDA | 2019-04-10 |
| Terminated | 2023-09-29 |
| Distributed | AZ, IN, TN |
| Reason classes | cgmp, specification failure |
| NDC | 68645-0494-54 |
| Lot numbers | 180190, 180191 |
| Expiration dates | 2020-10, 2021-02 |
Product
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54
Reason for recall
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
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-1075-2019. 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.