Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC… — Class II drug recall D-1286-2019
Terminated recall by Golden State Medical Supply Inc., reported 2019-05-29, distributed in IL, MI, MN, PA, TN, TX. CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished
| Recall number | D-1286-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Golden State Medical Supply Inc., Camarillo, CA, United States |
| Recall initiated | 2019-05-01 |
| Classified | 2019-05-19 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2020-02-25 |
| Distributed | IL, MI, MN, PA, TN, TX |
| Quantity | 8,767 hdpe |
| Reason classes | cgmp, specification failure |
| NDC | 60429-0318-10 |
| Expiration dates | 2019-06, 2019-12, 2020-01, 2020-02 |
Product
Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
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 at the manufacturer
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-1286-2019. 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.