Accupril Quinapril Tablets (Pfizer) – Nitrosamine Impurity (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
Brand
Pfizer Inc.
Lot Codes / Batch Numbers
Lots: DX6031 Exp. MAR 31 2023, CK6260 Exp. MAY 31 2022
Products Sold
Lots: DX6031 Exp. MAR 31 2023; CK6260 Exp. MAY 31 2022
Pfizer Inc. is recalling Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke- due to CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026