Sciegen Pharmaceuticals Inc recalls Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC
Sciegen Pharmaceuticals recalls Westminster Irbesartan 75mg tablets due to FDA-confirmed NDEA impurity. Stop using affected bottles immediately.
Recall notice
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Contact the company & request your remedy
What happened, in plain English
Sciegen Pharmaceuticals is recalling Westminster Irbesartan Tablets, 75mg, 30-count and 90-count bottles, because FDA testing found a harmful impurity (NDEA) that could pose health risks. This recall affects prescription-only medication that was manufactured in the USA and sold under specific NDC numbers. Read more at govinfonow.com/recall/39460-sciegen-westminster-irbesartan-tablets-recall-ndea-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39460-sciegen-westminster-irbesartan-tablets-recall-ndea-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0267-2019
Cite this page
“Sciegen Westminster Irbesartan Tablets Recall: NDEA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39460-sciegen-westminster-irbesartan-tablets-recall-ndea-impurity-risk. Based on FDA recall #D-0267-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0267-2019%22&limit=1).
Why it’s dangerous
FDA laboratory testing confirmed the presence of N-nitrosodimethylamine (NDEA), a known carcinogen, in the medication. This impurity could potentially cause health risks, including cancer, though the exact risk level isn't specified in the recall notice.
Who’s affected
Prescription holders of the Westminster Irbesartan Tablets, 75mg, 30-count (NDC 69367-119-01) or 90-count (NDC 69367-119-03) bottles. People with hypertension who require this medication are most at risk.
How to tell if you have this one
Check for the 30-count bottle (NDC 69367-119-01) or 90-count bottle (NDC 69367-119-03) labeled 'Westminster Irbesartan Tablets, USP, 75 mg'. These were manufactured in the USA and sold under prescription only.
- Brand
Sciegen Pharmaceuticals- Category
Drug
All 6 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-0267-2019 | Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA; 69367-119-01 Irbesartan 75mg Tablets, 30 count bottle B160002A Sep-19 69367-119-03 Irbesartan 75mg Tablets, 90 count bottle B160002B Sep-19 | 2,977 HDPE bottles |
| D-0268-2019 | Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made in the USA.; 69367-120-01 Irbesartan 150mg Tablets, 30 count bottle B161005A Sep-19 C161002A Feb-20 69367-120-03 Irbesartan 150mg Tablets, 90 count bottle B161005B Sep-19 C161002B Feb-20 | 5,061 HDPE bottles |
| D-0269-2019 | Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA.; 69367-121-01 Irbesartan 300mg Tablets, 30 count bottle B162008A Sep-19 C162002A Feb-20 69367-121-03 Irbesartan 300mg Tablets, 90 count bottle B162008B Sep-19 C162002B Feb-20 | 5,989 HDPE |
| D-0270-2019 | GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.; 60429-640-90 Irbesartan 75mg Tablets, 90 Count Bottle B160003 Sep-19 B160004 Sep-19 | 3,835 HDPE bottles |
| D-0271-2019 | GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.; 60429-641-90 Irbesartan 150mg Tablets, 90 Count Bottle B161003 Sep-19 B161004 Sep-19 B161006 Sep-19 B161007 Sep-19 B161008 Nov-19 B161009 Nov-19 B161010 Nov-19 C161001 Feb-20 C161003 May-20 60429-641-30 Irbesartan 150mg Tablets, 30 Count Bottle GS019526 Nov-19 GS020252 Nov-19 GS020958 Nov-19 | 18,760 HDPE bottles |
| D-0272-2019 | GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.; 60429-642-30 Irbesartan 300mg Tablets, 30 Count Bottle GS019036 Sep-19 GS019073 Sep-19 GS021472 Nov-19 GS021530 Nov-19 GS022234 Feb-20 60429-642-90 Irbesartan 300mg Tablets, 90 Count Bottle B162009 Sep-19 B162010 Sep-19 B162011 Sep-19 B162012 Nov-19 B162013 Nov-19 B162014 Nov-19 B162015 Nov-19 C162001 Feb-20 | 30,194 HDPE bottles |
What to do — step by step
Check Product Details
Identify if you have the 30-count or 90-count Westminster Irbesartan Tablets (NDC 69367-119-01 or 69367-119-03) prescribed by your doctor.
Questions people ask
Is this medication safe to use?
The recall notice states that FDA testing confirmed the presence of NDEA, a potential carcinogen, but does not specify if the medication is safe to use. The manufacturer has issued a recall, so it is recommended to stop using the affected products.
What should I do if I have the recalled medication?
The recall notice does not specify a remedy, so you should contact your doctor or the manufacturer for guidance on what to do with the medication.
How can I confirm if my medication is recalled?
Check the product label for the NDC numbers 69367-119-01 (30-count) or 69367-119-03 (90-count) on Westminster Irbesartan Tablets, 75mg.
Contact Sciegen Pharmaceuticals
We’ve drafted a message you can send Sciegen Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0267-2019 — Sciegen Pharmaceuticals Sciegen Pharmaceuticals Hello, I own a Sciegen Pharmaceuticals that is covered by recall D-0267-2019 from Sciegen 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-0267-2019 (October 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0267-2019 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.