Losartan Potassium Tablets 50 mg 1000 Tablets — Class II drug recall D-1458-2019
Terminated recall by Macleods Pharma Usa Inc, reported 2019-07-17, distributed nationwide. CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceuti
| Recall number | D-1458-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2019-06-20 |
| Classified | 2019-07-09 |
| Reported by FDA | 2019-07-17 |
| Terminated | 2021-10-26 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 33342-0044, 33342-0044-07, 33342-0044-10, 33342-0044-12, 33342-0044-44, 33342-0045, 33342-0045-07, 33342-0045-10, 33342-0045-12, 33342-0045-44, 33342-0046, 33342-0046-07, 33342-0046-10, 33342-0046-12, 33342-0046-44 |
Product
Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44
Reason for recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
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-1458-2019. 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.