Medications & Supplements/Prescription Drugs

Accuretic and Generic Quinapril Tablets Recalled for Excessive Impurities

Agency Publication Date: April 7, 2022

Summary

Pfizer Inc. has voluntarily recalled approximately 26,691 bottles of Accuretic (quinapril HCl/hydrochlorothiazide) and generic quinapril and hydrochlorothiazide tablets. These blood pressure medications are being recalled because they contain nitrosamine impurities at levels higher than the acceptable daily intake limit set by health authorities. No incidents or injuries have been reported to date. These prescription medications were manufactured in Germany and distributed to pharmacies across the United States.

Risk

The medications contain impurities called N-nitroso-quinapril and N-nitroso-hydrochlorothiazide. These nitrosamines are common in water and foods but may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

What You Should Do

This recall affects Accuretic (quinapril HCl/hydrochlorothiazide) and generic quinapril and hydrochlorothiazide tablets sold in 90-count bottles under the Parke-Davis (Division of Pfizer) and Greenstone brands.
Identify your medication by checking the brand name and the National Drug Code (NDC) on your prescription bottle. Affected NDC codes include 0071-0220-23, 0071-0223-23, 59762-5225-9, 59762-0220-1, 59762-0223-1, 0071-5212-23, 0071-3112-23, and 0071-0222-23. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mgby Parke-Davis (Pfizer)

Variants: 20 mg/12.5 mg, 90 tablets bottles

Lot Numbers:

EA6665 (Exp 04/2022)

CN0640 (Exp 04/2022)

NDC:

0071-0220-23

Recall #: D-0756-2022

Product: Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mgby Parke-Davis (Pfizer)

Variants: 20 mg/25 mg, 90 tablets bottles

Lot Numbers:

ET6974 (Exp 02/2023)

NDC:

0071-0223-23

Recall #: D-0757-2022

Product: quinapril and hydrochlorothiazide tablets, 20 mg/25 mgby Greenstone, LLC

Variants: 20 mg/25 mg, 90 tablets bottles

Lot Numbers:

FE3714 (Exp 02/2023)

NDC:

59762-5225-9

Recall #: D-0758-2022

Product: quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mgby Greenstone, LLC

Variants: 20 mg/12.5 mg, 90 tablets bottles

Lot Numbers:

DN6931 (Exp 03/2023)

ED3904 (Exp 03/2023)

ED3905 (Exp 03/2023)

NDC:

59762-0220-1

Recall #: D-0759-2022

Product: quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mgby Greenstone, LLC

Variants: 20 mg/25 mg, 90 tablets

Lot Numbers:

DP3414 (Exp 02/2023)

NDC:

59762-0223-1

Recall #: D-0760-2022

Product: Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mgby Parke-Davis (Pfizer)

Variants: 20 mg/12.5 mg, 90 tablets

Lot Numbers:

FG5381 (Exp 08/2024)

NDC:

0071-5212-23

Recall #: D-0761-2022

Product: Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mgby Parke-Davis (Pfizer)

Variants: 10 mg/12.5 mg, 90 tablets bottles

Lot Numbers:

FG5379 (Exp 08/2024)

NDC:

0071-3112-23

Recall #: D-0754-2022

Product: Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mgby Parke-Davis (Pfizer)

Variants: 10 mg/12.5 mg, 90 tablets bottle

Lot Numbers:

EA6686 (Exp 04/2022)

NDC:

0071-0222-23

Recall #: D-0755-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89864

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Pharmacies

Manufactured In: Germany

Units Affected: 8 products (53 bottles; 160 bottles; 1364 bottles; 265 bottles; 2442 bottles; 21108 bottles; 1104 bottles; 195 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Accuretic (quinapril HCl/hydrochlorothiazide) and generic quinapril and hydrochlorothiazide tablets sold in 90-count bottles under the Parke-Davis (Division of Pfizer) and Greenstone brands.

Identify your medication by checking the brand name and the National Drug Code (NDC) on your prescription bottle. Affected NDC codes include 0071-0220-23, 0071-0223-23, 59762-5225-9, 59762-0220-1, 59762-0223-1, 0071-5212-23, 0071-3112-23, and 0071-0222-23. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mgby Parke-Davis (Pfizer)

Variants: 20 mg/12.5 mg, 90 tablets bottles

Lot Numbers:

EA6665 (Exp 04/2022)

CN0640 (Exp 04/2022)

NDC:

0071-0220-23

Recall #: D-0756-2022

Product: Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mgby Parke-Davis (Pfizer)

Variants: 20 mg/25 mg, 90 tablets bottles

Lot Numbers:

ET6974 (Exp 02/2023)

NDC:

0071-0223-23

Recall #: D-0757-2022

Product: quinapril and hydrochlorothiazide tablets, 20 mg/25 mgby Greenstone, LLC

Variants: 20 mg/25 mg, 90 tablets bottles

Lot Numbers:

FE3714 (Exp 02/2023)

NDC:

59762-5225-9

Recall #: D-0758-2022

Product: quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mgby Greenstone, LLC

Variants: 20 mg/12.5 mg, 90 tablets bottles

Lot Numbers:

DN6931 (Exp 03/2023)

ED3904 (Exp 03/2023)

ED3905 (Exp 03/2023)

NDC:

59762-0220-1

Recall #: D-0759-2022

Product: quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mgby Greenstone, LLC

Variants: 20 mg/25 mg, 90 tablets

Lot Numbers:

DP3414 (Exp 02/2023)

NDC:

59762-0223-1

Recall #: D-0760-2022

Product: Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mgby Parke-Davis (Pfizer)

Variants: 20 mg/12.5 mg, 90 tablets

Lot Numbers:

FG5381 (Exp 08/2024)

NDC:

0071-5212-23

Recall #: D-0761-2022

Product: Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mgby Parke-Davis (Pfizer)

Variants: 10 mg/12.5 mg, 90 tablets bottles

Lot Numbers:

FG5379 (Exp 08/2024)

NDC:

0071-3112-23

Recall #: D-0754-2022

Product: Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mgby Parke-Davis (Pfizer)

Variants: 10 mg/12.5 mg, 90 tablets bottle

Lot Numbers:

EA6686 (Exp 04/2022)

NDC:

0071-0222-23

Recall #: D-0755-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89864

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Pharmacies

Manufactured In: Germany

Units Affected: 8 products (53 bottles; 160 bottles; 1364 bottles; 265 bottles; 2442 bottles; 21108 bottles; 1104 bottles; 195 bottles)

Distributed To: Nationwide