Pfizer is voluntarily recalling 5 lots of Accupril® (quinapril HCl) tablets due to the presence of a nitrosamine impurity, N-nitroso-quinapril, above the Food and Drug Administration’s (FDA) acceptable daily intake limit.

Accupril is indicated for the treatment of hypertension and for the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis.

The recalled lots of Accupril tablets are supplied in 90-count bottles and were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. The following is a list of the affected lots:

  • Strength 10mg; NDC Number 0071-0532-23; Lot Number DR9639; Expiration Date March 31, 2023; 
  • Strength 20mg; NDC Number 0071-0532-23; Lot Number DX8682; Expiration Date March 31, 2023; 
  • Strength 20mg; NDC Number 0071-0532-23; Lot Number DG1188; Expiration Date May 31, 2022; 
  • Strength 40mg; NDC Number 0071-0535-23; Lot Number DX6031; Expiration Date March 31, 2023;
  • Strength 40mg; NDC Number 0071-0535-23; Lot Number CK6260; Expiration Date May 31, 2022.

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 event reports related to this recall and believes there is no immediate risk to patients. Pfizer also maintains that the benefit/risk profile of the product remains positive based on currently available data. Alternative treatment options should be offered to patients who have received products affected by this recall.

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 Accupril®(quinapril HCl) due to N-Nitroso-quinapril content. News release. Biogen Inc. Accessed April 25, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuprilr-quinapril-hcl-due-n-nitroso-quinapril-content