Losartan Potassium Tablets — Class II drug recall D-0833-2022
Terminated recall by Macleods Pharma Usa Inc, reported 2022-05-11, distributed nationwide. CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
| Recall number | D-0833-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2022-04-15 |
| Classified | 2022-05-03 |
| Reported by FDA | 2022-05-11 |
| Terminated | 2023-10-13 |
| 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 |
| Lot numbers | BLI2002A, BLI2004A, BLI2104B |
| Expiration dates | 2022-11, 2023-05 |
Product
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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-0833-2022. 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.