CLASS II Drug recall · Reported 13 Apr 2022 · FDA Enforcement Report

quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg* recalled

Pfizer is recalling quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, distributed nationwide in the US. The recall was initiated on 21 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots DN6931, ED3904 & ED3905; Exp. 03/2023

Quantity recalled21108 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-0759-2022
FDA event ID: 89864
Recalling firm: Pfizer, New York, NY
Classification: Class II
Status: Terminated
Recall initiated: 21 Mar 2022
FDA classified: 6 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

21 Mar 2022	Recall initiated by company
6 Apr 2022	Classified by FDA	+16 days
13 Apr 2022	Published in enforcement report	+7 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: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

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

quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Which lots are affected?

Lots DN6931, ED3904 & ED3905; Exp. 03/2023

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

7 other products · FDA event 89864

This product is part of a recall event; the main page for the event is quinapril and hydrochlorothiazide tablets, 20 mg/25 mg* recalled.

Reported	Class	Recall	Company	Reason	Where
13 Apr 2022	CLASS II	quinapril and hydrochlorothiazide tablets, 20 mg/25 mg* recalled	Pfizer	Nitrosamine Impurity	Nationwide
13 Apr 2022	CLASS II	Accuretic (quinapril HCl/hydrochlorothiazide) tablets recalled by Pfizer	Pfizer	Nitrosamine Impurity	Nationwide
13 Apr 2022	CLASS II	Accuretic (quinapril HCl/hydrochlorothiazide) Tablets recalled by Pfizer	Pfizer	Nitrosamine Impurity	Nationwide
13 Apr 2022	CLASS II	quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg* recalled	Pfizer	Nitrosamine Impurity	Nationwide
13 Apr 2022	CLASS II	Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg recalled	Pfizer	Nitrosamine Impurity	Nationwide
13 Apr 2022	CLASS II	Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg recalled	Pfizer	Nitrosamine Impurity	Nationwide
13 Apr 2022	CLASS II	Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg recalled	Pfizer	Nitrosamine Impurity	Nationwide

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Other Quinapril recalls

All 14

Reported	Class	Recall	Company	Reason	Where
28 Dec 2022Drug	CLASS II	Quinapril Tablets USP, 40 mg recalled by Lupin PharmaceuticalsQuinapril	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
28 Dec 2022Drug	CLASS II	Quinapril Tablets USP, 20 mg recalled by Lupin PharmaceuticalsQuinapril	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
2 Nov 2022Drug	CLASS II	Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg recalledQuinapril Hydrochloride/hydrochlorothiazide	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
13 Apr 2022Drug	CLASS II	quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg* recalled	Pfizer	Nitrosamine Impurity	Nationwide
13 Apr 2022Drug	CLASS II	quinapril and hydrochlorothiazide tablets, 20 mg/25 mg* recalled	Pfizer	Nitrosamine Impurity	Nationwide