Sandoz Losartan Potassium and Hydrochlorothiazide Tablets — Class II drug recall D-0359-2019
Ongoing recall by Sandoz, Inc, reported 2018-12-05, distributed in OH, PR. CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API use
| Recall number | D-0359-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz, Inc, Princeton, NJ, United States |
| Recall initiated | 2018-11-01 |
| Classified | 2019-01-14 |
| Reported by FDA | 2018-12-05 |
| Distributed | OH, PR |
| Quantity | 170 hdpe |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 00781-5207-10 |
| Lot numbers | JB8912 |
| Expiration dates | 2020-06 |
Product
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.
Reason for recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
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-0359-2019. 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.