CLASS II Drug recall · Reported 28 Nov 2018 · FDA Enforcement Report

Westminister Irbesartan Tablets, USP, 150 mg, (a) bottle recalled

Sciegen Pharmaceuticals is recalling Westminister Irbesartan Tablets, USP, 150 mg, (a) bottle (, distributed nationwide in the US. The recall was initiated on 29 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes69367-120-01 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

Quantity recalled5,061 HDPE bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0268-2019
FDA event ID: 81458
Recalling firm: Sciegen Pharmaceuticals, Hauppauge, NY
Classification: Class II
Status: Terminated
Recall initiated: 29 Oct 2018
FDA classified: 20 Nov 2018
Reported: 28 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

29 Oct 2018	Recall initiated by company
20 Nov 2018	Classified by FDA	+22 days
28 Nov 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

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.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Which lots are affected?

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

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 81458

This product is part of a recall event; the main page for the event is Westminister Irbesartan Tablets, USP, 75 mg (a) bottle recalled.

Reported	Class	Recall	Company	Reason	Where
28 Nov 2018	CLASS II	Westminister Irbesartan Tablets, USP, 75 mg (a) bottle recalled	Sciegen Pharmaceuticals	Nitrosamine Impurity	Nationwide
28 Nov 2018	CLASS II	GSMS Irbesartan Tablets, USP, 150 mg, (a) bottle recalled	Sciegen Pharmaceuticals	Nitrosamine Impurity	Nationwide
28 Nov 2018	CLASS II	GSMS Irbesartan Tablets, USP, 75 mg recalled by Sciegen Pharmaceuticals	Sciegen Pharmaceuticals	Nitrosamine Impurity	Nationwide
28 Nov 2018	CLASS II	GSMS Irbesartan Tablets, USP, 300 mg,(a) bottle recalled	Sciegen Pharmaceuticals	Nitrosamine Impurity	Nationwide
28 Nov 2018	CLASS II	Westminister Irbesartan Tablets, USP, 300mg recalled	Sciegen Pharmaceuticals	Nitrosamine Impurity	Nationwide

More recalls from Sciegen Pharmaceuticals

All 7

Reported	Class	Recall	Company	Reason	Where
8 Mar 2023Drug	CLASS III	Gabapentin Tablets, USP 600 mg recalled by Sciegen PharmaceuticalsGabapentin	Sciegen Pharmaceuticals	Other	Nationwide
28 Nov 2018Drug	CLASS II	Westminister Irbesartan Tablets, USP, 300mg recalled	Sciegen Pharmaceuticals	Nitrosamine Impurity	Nationwide
28 Nov 2018Drug	CLASS II	GSMS Irbesartan Tablets, USP, 300 mg,(a) bottle recalled	Sciegen Pharmaceuticals	Nitrosamine Impurity	Nationwide
28 Nov 2018Drug	CLASS II	GSMS Irbesartan Tablets, USP, 75 mg recalled by Sciegen Pharmaceuticals	Sciegen Pharmaceuticals	Nitrosamine Impurity	Nationwide
28 Nov 2018Drug	CLASS II	GSMS Irbesartan Tablets, USP, 150 mg, (a) bottle recalled	Sciegen Pharmaceuticals	Nitrosamine Impurity	Nationwide

Other Westminister Irbesartan recalls

All 3

Reported	Class	Recall	Company	Reason	Where
28 Nov 2018Drug	CLASS II	Westminister Irbesartan Tablets, USP, 300mg recalled	Sciegen Pharmaceuticals	Nitrosamine Impurity	Nationwide
28 Nov 2018Drug	CLASS II	Westminister Irbesartan Tablets, USP, 75 mg (a) bottle recalled	Sciegen Pharmaceuticals	Nitrosamine Impurity	Nationwide