Losartan Potassium Tablets — Class II drug recall D-1263-2019
Ongoing recall by Legacy Pharmaceutical Packaging LLC, reported 2019-05-08, distributed in AZ, TN. CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active
| Recall number | D-1263-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Legacy Pharmaceutical Packaging LLC, Earth City, MO, United States |
| Recall initiated | 2019-04-24 |
| Classified | 2019-05-01 |
| Reported by FDA | 2019-05-08 |
| Distributed | AZ, TN |
| Quantity | 60,012 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 68645-0494-54 |
| Lot numbers | 181598 |
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: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
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-1263-2019. 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.