CLASS II Drug recall · Reported 25 May 2022 · FDA Enforcement Report
Accupril (Quinapril HCl Tablets) 10 mg recalled by Pfizer
Pfizer is recalling Accupril (Quinapril HCl Tablets) 10 mg, distributed nationwide in the US. The recall was initiated on 22 Apr 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0872-2022
- FDA event ID
- 90064
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2022
- FDA classified
- 16 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 22 Apr 2022 | Recall initiated by company | |
| 16 May 2022 | Classified by FDA | +24 days |
| 25 May 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Accupril (Quinapril HCl Tablets) 10 mg recalled?
Yes. Pfizer recalled Accupril (Quinapril HCl Tablets) 10 mg on 22 Apr 2022. The recall is Class II and its status is Terminated. Recall number D-0872-2022.
Why was it recalled?
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Which lots are affected?
Lot: DR9639 Exp. MAR 31 2023
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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