Pfizer is voluntarily recalling 6 lots of Accuretic (quinapril HCl/hydrochlorothiazide) tablets and 2 authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) due to the presence of N-nitroso-quinapril, a nitrosamine impurity.

Long-term use of products containing nitrosamine impurities may be associated with a potential increased cancer risk, though the Company is not aware of any adverse events reports related to this recall and believes there is no immediate risk to patients. Pfizer also maintains that the benefit/risk profile of these antihypertensive agents remains positive based on currently available data. Alternative treatment options should be offered to patients who have received products affected by this recall.

The recalled lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from November 2019 to March 2022. 

The affected lots of Accuretic (quinapril HCl/hydrochlorothiazide) 10/12.5mg, 20/12.5mg, and 20/25mg tablets were supplied in 90-count bottles and include the following:

StrengthNDCLot NumberExpiration
10/12.5mg0071-3112-23FG537908/2024
10/12.5mg0071-0222-23EA668604/2022
20/12.5mg0071-5212-23FG538108/2024
20/12.5mg0071-0220-23EA666504/2022
20/12.5mg0071-0220-23CN064004/2022
20/25mg0071-0223-23ET697402/2023

The affected lots of quinapril and hydrochlorothiazide 20/25mg tablets, quinapril HCl/hydrochlorothiazide 20/12.5mg tablets, and quinapril HCl/hydrochlorothiazide 20/25mg tablets were supplied in 90-count bottles and include the following:

StrengthNDCLot NumberExpiration
20/12.5mg59762-0220-1DN693103/2023
20/12.5mg59762-0220-1ED390403/2023
20/12.5mg59762-0220-1ED390503/2023
20/25mg59762-5225-9FE371402/2023
20/25mg59762-0223-1DP341402/2023

Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.

Reference

Pfizer voluntary nationwide recall of lots of Accuretic (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide tablets, and quinapril hcl/hydrochlorothiazide tablets due to N-NitrosoQuinapril content. News release. Pfizer Inc. Accessed March 23, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuretictm-quinapril-hclhydrochlorothiazide-quinapril-and