Aurobindo Pharma Limited (Unit I) recalls Irbesartan Bulk Active Pharmaceutical Ingredient.
Aurobindo Pharma recalls irbesartan bulk active pharmaceutical ingredient due to detected carcinogen NDEA impurity. Affected batches contain specific manufacturing and dispatch numbers. Consumers should contact manufacturer for details.
Lower-risk recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Contact the company & request your remedy
What happened, in plain English
Aurobindo Pharma is recalling irbesartan bulk active pharmaceutical ingredient because it contains NDEA, a known carcinogen. This impurity was found during manufacturing, which could pose cancer risks if used in final medications. Read more at govinfonow.com/recall/39475-aurobindo-pharma-irbesartan-bulk-ingredient-recall-ndea-carcinogen-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/39475-aurobindo-pharma-irbesartan-bulk-ingredient-recall-ndea-carcinogen-impurity · Updated October 5, 2026 · FDA enforcement record: FDA #D-0127-2019
Cite this page
“Aurobindo Pharma Irbesartan Bulk Ingredient Recall: NDEA Carcinogen Impurity.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39475-aurobindo-pharma-irbesartan-bulk-ingredient-recall-ndea-carcinogen-impurity. Based on FDA recall #D-0127-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0127-2019%22&limit=1).
Why it’s dangerous
NDEA (N-Nitrosodimethylamine) is a carcinogen that can cause cancer when ingested. The presence of this impurity in the active pharmaceutical ingredient means that medications made from this batch could contain harmful levels of the carcinogen.
Who’s affected
Manufacturers and facilities using this bulk ingredient for final medications are affected. Those producing medications containing this ingredient may be at risk of exposure to the carcinogen.
How to tell if you have this one
Check for manufacturing batch numbers listed in the recall: 1601100782, 1601100783, 1701111861, 1701112170, 1701112501, 1701112056, 1701112558, 1701112559, 1701112589, 1701113300, 1701113301, 1701113302, 1701113312, 1701115460, 1701115974, and 1701115738. The dispatch batch numbers and expiration dates are also listed in the recall.
- Brand
Aurobindo Pharma- Category
Drug
What to do — step by step
Contact Manufacturer
Reach out to Aurobindo Pharma Limited (Unit I) for specific batch details and instructions on handling affected products.
Questions people ask
What is the specific impurity in the recalled product?
The recall involves irbesartan bulk active pharmaceutical ingredient with NDEA (N-Nitrosodimethylamine), a known carcinogen.
How can I tell if I have the recalled product?
Check for manufacturing batch numbers listed in the recall: 1601100782, 1601100783, 1701111861, 1701112170, 1701112501, 1701112056, 1701112558, 1701112559, 1701112589, 1701113300, 1701113301, 1701113302, 1701113312, 1701115460, 1701115974, and 1701115738.
Do I need to stop using this product?
This is a bulk ingredient used in medications, not a final product. Consumers are not directly affected unless they are manufacturing medications with this ingredient.
Contact Aurobindo Pharma
We’ve drafted a message you can send Aurobindo Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0127-2019 — Aurobindo Pharma Aurobindo Pharma Hello, I own a Aurobindo Pharma that is covered by recall D-0127-2019 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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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-0127-2019 (October 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0127-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.