Losartan Potassium Tablets USP 50 mg — Class II drug recall D-1103-2020
Terminated recall by Avet Pharmaceuticals, Inc., reported 2020-04-15, distributed nationwide. CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished
| Recall number | D-1103-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avet Pharmaceuticals, Inc., East Brunswick, NJ, United States |
| Recall initiated | 2020-03-26 |
| Classified | 2020-04-07 |
| Reported by FDA | 2020-04-15 |
| Terminated | 2021-03-08 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 23155-0645-03, 23155-0645-09, 23155-0645-10 |
| Expiration dates | 2020-03-20 |
Product
Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09
Reason for recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
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-1103-2020. 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.