The Recall Desk
HighFDA (Drugs)·D-0874-2022·Announced 2022-05-25

Pfizer Accupril Blood Pressure Tablets Recalled for Nitrosamine Contamination

Pfizer is recalling specific lots of Accupril (quinapril HCl) 40 mg tablets distributed nationwide and in Puerto Rico because the product contains N-nitrosoquinapril above acceptable limits, a manufacturing deviation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving pharmaceutical contamination with nitrosamine impurity above acceptable limits. No illnesses or injuries have been reported. Nitrosamines are recognized as a potential health hazard, classifying this as a risk-of-harm product; however, the absence of adverse events and absence of hospitalization reports preclude a higher severity score.

Plain-English summary

Pfizer Inc. is recalling specific lots of Accupril (Quinapril HCl Tablets), a prescription-only medication in the 40 mg strength. Each bottle contains 90 tablets. The recalled lots are identified as DX6031 (expiration March 31, 2023) and CK6260 (expiration May 31, 2022). Approximately 8,346 bottles are affected by the recall.

The recall is due to a manufacturing deviation in which the product contains N-nitrosoquinapril above acceptable limits.

The affected product was distributed nationwide and in Puerto Rico by Parke-Davis Division of Pfizer Inc.

The recalled product

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
Manufacturer
Pfizer Inc.
Category
Drug
Hazard
  • nitrosamine
  • cgmp-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lots: DX6031 Exp. MAR 31 2023
  • CK6260 Exp. MAY 31 2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category