Quinapril and Hydrochlorothiazide Tablets Recalled for Elevated Chemical Impurity
Pfizer is recalling quinapril and hydrochlorothiazide tablets (20 mg/25 mg) nationwide due to elevated chemical impurities exceeding acceptable daily intake limits. No illnesses have been reported.
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 is an FDA Class II recall with no reported illnesses or injuries. The recall is due to a manufacturing quality deviation (elevated chemical impurity) without documented patient harm, fitting the category of precautionary recalls based on theoretical risk.
Plain-English summary
Pfizer Inc. is recalling quinapril and hydrochlorothiazide tablets, 20 mg/25 mg strength, distributed nationwide. The recall involves 2,442 bottles bearing lot number FE3714 with an expiration date of February 2023.
The recall was initiated due to manufacturing quality deviations (CGMP violations). Testing revealed that N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurities in the product exceeded the acceptable daily intake limits established by the FDA.
Patients currently taking this medication should contact their healthcare provider or pharmacist to confirm whether they received the recalled product and discuss their treatment options. Anyone with the affected product should consult their healthcare provider before taking any action.
The recalled product
- Product
- quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9
- Manufacturer
- Pfizer Inc.
- Category
- Drug
- Hazard
- impurity
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 FE3714
- Exp. 02/2023
Distribution
Distributed nationwide across the United States.
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