Pfizer Accuretic Blood Pressure Tablets Recalled for Chemical Impurity
Pfizer is recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets nationwide due to unacceptable levels of N-nitroso chemical impurities from manufacturing deviations. The affected lot includes 160 bottles.
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: This FDA Class II recall involves chemical impurities (N-nitroso compounds) above acceptable daily intake limits, representing a risk-of-harm product. No illnesses or injuries have been reported, placing it in the High category per the severity rubric.
Plain-English summary
Pfizer Inc. is recalling Accuretic (quinapril HCl/hydrochlorothiazide) 10 mg/12.5 mg tablets nationwide. The recall affects 160 bottles from lot EA6686 with an expiration date of April 2022. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that resulted in N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurities at levels above the acceptable daily intake limit.
N-nitroso compounds pose potential health risks. While no illnesses or injuries have been reported to date, patients who received tablets from the affected lot may have been exposed to these impurities at higher than normally acceptable levels.
Patients who believe they may have tablets from lot EA6686 should contact their healthcare provider or pharmacist immediately. They can verify the lot number on their medication bottle. Healthcare providers can advise on appropriate next steps.
The recalled product
- Product
- Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23
- Manufacturer
- Pfizer Inc.
- Category
- Drug
- Hazard
- chemical-impurity
- carcinogen-risk
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)
- Lot EA6686
- Exp. 04/2022
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateTopCare Earwax Removal Kit Recalled for Subpotent Drug Content
FDA (Drugs) · 2026-07-22