Losartan Potassium and Hydrochlorothiazide Tablets — Class II drug recall D-1045-2019
Terminated recall by AVKARE Inc., reported 2019-03-27, distributed nationwide. CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
| Recall number | D-1045-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2019-03-05 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2020-12-07 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 50268-0513-15 |
| Lot numbers | 19454 |
| Expiration dates | 2019-04-30 |
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
Reason for recall
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
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-1045-2019. 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.