Westminster Pharmaceuticals Llc recalls Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788
Westminster Pharmaceuticals recalls 75mg Irbesartan tablets with traces of NDEA impurity found in specific batches. FDA testing confirmed contamination in certain lots.
Stop using this now
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Contact the company & request your remedy
What happened, in plain English
Westminster Pharmaceuticals is recalling 75mg Irbesartan tablets that contain traces of NDEA impurity. This impurity can cause serious health risks, so affected consumers should stop using the product. Read more at govinfonow.com/recall/39465-westminster-irbesartan-tablets-75mg-ndea-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39465-westminster-irbesartan-tablets-75mg-ndea-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0300-2019
Cite this page
“Westminster Irbesartan Tablets 75mg: NDEA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39465-westminster-irbesartan-tablets-75mg-ndea-impurity-risk. Based on FDA recall #D-0300-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0300-2019%22&limit=1).
Why it’s dangerous
FDA testing found traces of NDEA impurity in specific batches of Irbesartan tablets. NDEA is a known carcinogen that can cause serious health issues when ingested over time.
Who’s affected
People who have the specific 30-count or 90-count bottles with the listed NDC numbers and batch dates are affected. Those taking this medication for blood pressure should be most at risk.
How to tell if you have this one
Check for 30-count bottles with NDC 69367-119-01 or 90-count bottles with NDC 69367-119-03. The batch numbers are B160002A (expiring 09/30/2019) or B160002B (same expiration).
- Brand
Westminster Pharmaceuticals- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0300-2019 | Westminster Irbesartan Tablets, USP 75 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 69367-119-01; b) 90 count bottle NDC 69367-119-03; Batch Numbers: a) B160002A Exp. 09/30/2019; b) B160002B Exp. 09/30/2019 | 1571 bottles |
| D-0301-2019 | 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; Batch Numbers: a) B161005A Exp. 09/30/2019, C161002A Exp. 02/29/2020; b) B161005B Exp. 09/30/2019, C161002B Exp. 02/29/2020 | 2319 bottles |
| D-0302-2019 | Westminster Irbesartan Tablets, USP 300 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 69367-121-01; b) 90 count bottle NDC 69367-121-03; Batch Numbers: a) B162008A Exp. 09/30/2019, C162002A Exp. 02/29/2020; b) B162008B Exp. 09/30/2019, C162002B Exp. 02/29/2020 | 3976 bottles |
What to do — step by step
Stop Using Now
Immediately stop using the recalled tablets as they contain traces of NDEA impurity that can cause serious health risks.
Questions people ask
Why is this medication being recalled?
FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan tablets, which can cause serious health risks.
What is the NDEA impurity?
NDEA is a known carcinogen that can cause serious health issues when ingested over time.
How can I check if I have the recalled product?
Check for 30-count bottles with NDC 69367-119-01 or 90-count bottles with NDC 69367-119-03, with batch numbers B160002A or B160002B expiring 09/30/2019.
Contact Westminster Pharmaceuticals
We’ve drafted a message you can send Westminster Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0300-2019 — Westminster Pharmaceuticals Westminster Pharmaceuticals Hello, I own a Westminster Pharmaceuticals that is covered by recall D-0300-2019 from Westminster Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0300-2019 (October 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0300-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.