The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0758-2022·Announced 2022-04-13

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units
2,442

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.

Part of a larger recall action

This product is one of 8 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · Pfizer Inc.

See all →

Same hazard · impurity

See all →

Similar recalls