CLASS II Drug recall · Reported 10 Nov 2021 · FDA Enforcement Report

Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) recalled

Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) (, distributed nationwide in the US. The recall was initiated on 12 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) Lot# H804537, exp. date 30/09/2021 H805148, exp. date 31/10/2021 H900063, exp. date 31/10/2021 H900522, exp. date 31/12/2021 H901582, exp. date 31/01/2022 b) Lot# H000963, exp. date 30/04/2022 H804507, exp. date 30/04/2022 H804536, exp. date 30/09/2021 H805070, exp. date 31/10/2021 H805149, exp. date 31/10/2021 H900064, exp. date 31/12/2021 H900523, exp. date 31/01/2022 H901583, exp. date 30/04/2022 H902530, exp. date 30/04/2022

Quantity recalled63,408 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-0089-2022
FDA event ID: 88856
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Classification: Class II
Status: Terminated
Recall initiated: 12 Oct 2021
FDA classified: 1 Nov 2021
Reported: 10 Nov 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

12 Oct 2021	Recall initiated by company
1 Nov 2021	Classified by FDA	+20 days
10 Nov 2021	Published in enforcement report	+9 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: impurity N-nitrosoirbesartan detected in API

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

Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only

Where it was distributed

Product was distributed to major distributors who may have further distributed the product nationwide.

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Which lots are affected?

a) Lot# H804537, exp. date 30/09/2021 H805148, exp. date 31/10/2021 H900063, exp. date 31/10/2021 H900522, exp. date 31/12/2021 H901582, exp. date 31/01/2022 b) Lot# H000963, exp. date 30/04/2022 H804507, exp. date 30/04/2022 H804536, exp. date 30/09/2021 H805070, exp. date 31/10/2021 H805149, exp. date 31/10/2021 H900064, exp. date 31/12/2021 H900523, exp. date 31/01/2022 H901583, exp. date 30/04/2022 H902530, exp. date 30/04/2022

Where was it sold?

Product was distributed to major distributors who may have further distributed the product 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

4 other products · FDA event 88856

This product is part of a recall event; the main page for the event is Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) recalled.

Reported	Class	Recall	Company	Reason	Where
10 Nov 2021	CLASS II	Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) recalled	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
10 Nov 2021	CLASS II	Irbesartan Tablets USP, 150 mg a) recalled by Lupin PharmaceuticalsIrbesartan	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
10 Nov 2021	CLASS II	Irbesartan Tablets USP, 300 mg a) recalled by Lupin PharmaceuticalsIrbesartan	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
10 Nov 2021	CLASS II	Irbesartan Tablets USP, 75 mg a) recalled by Lupin PharmaceuticalsIrbesartan	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide

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Other Irbesartan recalls

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Reported	Class	Recall	Company	Reason	Where
19 Feb 2025Drug	CLASS II	Irbesartan Tablets USP, 300 mg Dose recalled by AvKARE	AvKARE	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
10 Nov 2021Drug	CLASS II	Irbesartan Tablets USP, 75 mg a) recalled by Lupin PharmaceuticalsIrbesartan	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
10 Nov 2021Drug	CLASS II	Irbesartan Tablets USP, 300 mg a) recalled by Lupin PharmaceuticalsIrbesartan	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide