CLASS II Drug recall · Reported 6 Feb 2019 · FDA Enforcement Report

Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalled

Prinston Pharmaceutical is recalling Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg, distributed nationwide in the US. The recall was initiated on 18 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes327A18001 327A18002

NDC43547-330, 43547-331

UPC0343547331030, 0343547330033

Quantity recalled32692 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-0411-2019
FDA event ID: 81910
Recalling firm: Prinston Pharmaceutical, Somerset, NJ
Brand: Irbesartan And Hydrochlorothiazide
Manufacturer: Solco Healthcare US, LLC
Classification: Class II
Status: Completed
Recall initiated: 18 Jan 2019
FDA classified: 27 Jan 2019
Reported: 6 Feb 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

18 Jan 2019	Recall initiated by company
27 Jan 2019	Classified by FDA	+9 days
6 Feb 2019	Published in enforcement report	+10 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 lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

327A18001 327A18002

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 21 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 81910

Reported	Class	Recall	Company	Reason	Where
6 Feb 2019	CLASS II	Irbesartan Tablets 300 mg recalled by Prinston PharmaceuticalIrbesartan	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide
6 Feb 2019	CLASS II	Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalledIrbesartan And Hydrochlorothiazide	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide
6 Feb 2019	CLASS II	Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx Only recalledIrbesartan And Hydrochlorothiazide	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide
6 Feb 2019	CLASS II	Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg recalledIrbesartan And Hydrochlorothiazide	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide

More recalls from Prinston Pharmaceutical

All 16

Reported	Class	Recall	Company	Reason	Where
6 Feb 2019Drug	CLASS II	Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg recalledIrbesartan And Hydrochlorothiazide	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide
6 Feb 2019Drug	CLASS II	Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx Only recalledIrbesartan And Hydrochlorothiazide	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide
6 Feb 2019Drug	CLASS II	Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalledIrbesartan And Hydrochlorothiazide	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide
6 Feb 2019Drug	CLASS II	Irbesartan Tablets 300 mg recalled by Prinston PharmaceuticalIrbesartan	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide
1 Aug 2018Drug	CLASS II	Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12 recalledValsartan And Hydrochlorothiazide	Prinston Pharmaceutical	Potency & Assay	NJ

Other Irbesartan recalls

All 16

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