Westminster Irbesartan Tablets — Class II drug recall D-0301-2019
Terminated recall by Westminster Pharmaceuticals Llc, reported 2018-12-19, distributed nationwide. CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
| Recall number | D-0301-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Westminster Pharmaceuticals Llc, Olive Branch, MS, United States |
| Recall initiated | 2018-10-29 |
| Classified | 2018-12-14 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2021-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 2,319 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 69367-0120-01, 69367-0120-03 |
| Expiration dates | 2019-09-30, 2020-02-29 |
Product
Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-120-01; b) 90 count bottle NDC 69367-120-03
Reason for recall
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
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-0301-2019. 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.