Quinapril Tablets USP
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Most common reason: Nitrosamine impurity (14 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Quinapril. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Failed Impurities/Degradation Specifications; Impurity A
Subpotent Drug
Subpotent Drug
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Labeling:Label Mixup; QUINAPRIL HCL, Tablet, 20 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: W003553, EXP: 6/24/2014.
Labeling:Label Mixup; QUINAPRIL HCL Tablet, 10 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 80 mg, NDC 23155011401, Pedigree: AD42566_4, EXP: 5/14/2014.
Labeling: Label Mixup; QUINAPRIL Tablet, 40 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 16714002104, Pedigree: AD52778_73, EXP: 5/21/2014.
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