Aurobindo Recalls Quinapril/HCTZ Tablets Due to Impurity
Aurobindo Pharma recalls specific lots of Quinapril and Hydrochlorothiazide tablets due to N-Nitroso-quinapril impurity exceeding acceptable limits.
Use caution until it’s fixed
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
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What happened, in plain English
Aurobindo Pharma USA Inc. is recalling bottles of Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg because they contain an impurity above the acceptable daily intake limit. The specific lots affected were manufactured in India and distributed nationwide. This recall addresses current Good Manufacturing Practice (CGMP) deviations related to the detection of N-Nitroso-quinapril. Read more at govinfonow.com/recall/34305-aurobindo-recalls-quinapril-hctz-tablets-due-to-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/34305-aurobindo-recalls-quinapril-hctz-tablets-due-to-impurity · Updated October 10, 2026 · FDA enforcement record: FDA #D-0021-2023
Cite this page
“Aurobindo Recalls Quinapril/HCTZ Tablets Due to Impurity.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/34305-aurobindo-recalls-quinapril-hctz-tablets-due-to-impurity. Based on FDA recall #D-0021-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0021-2023%22&limit=1).
Why it’s dangerous
The recalled tablets contain N-Nitroso-quinapril impurity above the acceptable daily intake limit. This deviation from current Good Manufacturing Practices means the medication may not meet safety standards regarding this specific chemical impurity.
Who’s affected
Patients who have been prescribed or are currently taking Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg from the affected lots. Individuals with bottles distributed by Aurobindo Pharma USA Inc. should check their lot numbers.
How to tell if you have this one
Check your bottle for the following details: Product is Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg in 90-Tablet bottles. Look for NDC 65862-162-90. Verify the lot number is either QE2021005-A or QE2021010-A with an expiration date of 01/2023.
- Brand
Aurobindo Pharma- Category
Drug
What to do — step by step
Check your medication
Verify if your bottle matches the NDC, lot numbers (QE2021005-A or QE2021010-A), and expiration date (01/2023) listed in the recall.
Consult your healthcare provider
Contact your doctor or pharmacist to discuss alternative treatment options if you have been taking these specific recalled tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-0021-2023 (October 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0021-2023 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.