The Recall Desk
ModerateFDA (Drugs)·D-0872-2022·Announced 2022-05-25

Accupril tablets recalled by Pfizer for nitrosamine impurity

Pfizer is recalling 2,079 bottles of Accupril (Quinapril HCl) 10 mg tablets due to N-nitrosoquinapril exceeding acceptable limits. The affected lot was distributed nationwide and in Puerto Rico.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class II recall addresses a manufacturing deviation with an impurity above acceptable limits. No illnesses or injuries have been reported. This is a precautionary recall without reported harm, consistent with Moderate severity.

Plain-English summary

Pfizer Inc. is recalling 2,079 bottles of Accupril (Quinapril HCl Tablets) 10 mg due to a manufacturing deviation. The recalled lot contains N-nitrosoquinapril at levels above what is acceptable according to manufacturing standards.

The affected lot is Lot DR9639 with an expiration date of March 31, 2023 (NDC 0071-0530-23). The product was distributed nationwide and in Puerto Rico.

Patients currently using this medication should consult their healthcare provider or pharmacist before making any changes to their treatment. Consumers with this specific lot should contact Pfizer or their pharmacy for instructions on return or replacement.

The recalled product

Product
Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
Manufacturer
Pfizer Inc.
Category
Drug — Prescription Medication / ACE Inhibitor
Hazard
  • nitrosamine-impurity
  • manufacturing-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 (1)

  • Lot: DR9639 Exp. MAR 31 2023

Distribution

Distributed nationwide across the United States.

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