Aurobindo Pharma USA recalls 20mg/12.5mg Quinapril and Hydrochlorothiazide tablets due to N-Nitroso-quinapril impurity exceeding safe levels. Consumers should check NDC 65862-162-90 and lots QE2021005-A/QE2021010-A.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Aurobindo Pharma is recalling 90-tablet bottles of Quinapril and Hydrochlorothiazide tablets (20mg/12.5mg) because they contain an impurity that could exceed safe levels. This recall affects people taking blood pressure medication who might have been exposed to the impure tablets.
The tablets contain N-Nitroso-quinapril impurities above the acceptable daily intake limit. This impurity could potentially cause health issues if consumed over time, but the risk is not immediately life-threatening.
People who have the specific 90-tablet bottles of Quinapril and Hydrochlorothiazide tablets (20mg/12.5mg) with NDC 65862-162-90 and lots QE2021005-A or QE2021010-A. Those taking blood pressure medication are most at risk if they used the recalled product.
Check for the NDC code 65862-162-90 on the bottle label. The product was made in India with lots QE2021005-A and QE2021010-A, expiring January 2023.
Look for the NDC code 65862-162-90 and lots numbers QE2021005-A or QE2021010-A on the bottle.
The product contains an impurity that could exceed safe levels, but the risk is low. Consumers should check if they have the recalled batch numbers.
Check the NDC code 65862-162-90 and lots numbers QE2021005-A or QE2021010-A on the bottle label.
The recall does not specify a return or disposal step, so check with the manufacturer for guidance.
We’ve drafted a message you can send Aurobindo Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0021-2023 — Aurobindo Pharma Aurobindo Pharma Hello, I own a Aurobindo Pharma that is covered by recall D-0021-2023 from Aurobindo Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
