Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC
Aurobindo Pharma recalls 40mg Valsartan tablets due to trace NDEA impurity found in manufacturing. Affected lots from Feb 2020 to May 2020. No specific action steps listed in recall notice.
Recall notice
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Contact the company & request your remedy
What happened, in plain English
Aurobindo Pharma is recalling 40mg Valsartan tablets that may contain trace amounts of NDEA, a potential carcinogen. This recall is due to FDA-confirmed impurities in the manufacturing process, though no injuries have been reported. The product is prescription-only and distributed through specific lot numbers with expiration dates. Read more at govinfonow.com/recall/39280-aurobindo-valsartan-tablets-40mg-recall-trace-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39280-aurobindo-valsartan-tablets-40mg-recall-trace-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1037-2019
Cite this page
“Aurobindo Valsartan Tablets 40mg Recall: Trace Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39280-aurobindo-valsartan-tablets-40mg-recall-trace-impurity-risk. Based on FDA recall #D-1037-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1037-2019%22&limit=1).
Why it’s dangerous
The FDA found trace amounts of N-nitrosodiethylamine (NDEA), a known carcinogen, in the active ingredient used to make these tablets. While the amounts are very small, the presence of this impurity could pose a potential cancer risk with long-term use. The impurity was detected during manufacturing quality checks.
Who’s affected
Prescription patients who have the specific lot numbers of Valsartan tablets (470180008A, 470180014A, 470180016A, 470180032A) with expiration dates from February to May 2020. Those using the product without a prescription are not affected.
How to tell if you have this one
Check your prescription bottle for the lot numbers: 470180008A (expires Feb 2020), 470180014A, 470180016A (expires Mar 2020), or 470180032A (expires May 2020). The product is only available by prescription and has a specific NDC number.
- Brand
Aurobindo Pharma- Category
Drug
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Product was distributed to major distribution chains throughout the United States.
| Recall number | Product, codes & lots | NDC |
|---|---|---|
| D-1035-2019 | Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90; Lot Numbers: 473180004A, 473180005A, exp. date Feb 2020; 473180006A, exp. date Mar 2020; 473180016A, 473180017A, exp. date May 2020; 473170019A, exp. date Oct 2019 | 65862-570-30, 65862-570-99, 65862-570-10, 65862-571-90, 65862-571-99, 65862-571-10, 65862-572-90, 65862-572-99, 65862-572-10, 65862-573-90, 65862-573-05 |
| D-1036-2019 | Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30; Lot Numbers: VFSA17007-A, exp. date Oct-2019 | 65862-737-30, 65862-737-90, 65862-737-10, 65862-737-03, 65862-739-30, 65862-739-90, 65862-739-10, 65862-739-03, 65862-738-30, 65862-738-90, 65862-738-10, 65862-738-03, 65862-740-30, 65862-740-90, 65862-740-10, 65862-740-03 |
| D-1037-2019 | Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30; Lot Numbers: 470180008A, exp. date Feb 2020; 470180014A, 470180016A, exp. date Mar 2020; 470180032A, exp. date May 2020 | 65862-570-30, 65862-570-99, 65862-570-10, 65862-571-90, 65862-571-99, 65862-571-10, 65862-572-90, 65862-572-99, 65862-572-10, 65862-573-90, 65862-573-05 |
| D-1038-2019 | Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90; Lot Numbers: 471170015A, exp. date Sep 2019; 471180004A, 471180005A, exp. date Feb 2019 | 65862-570-30, 65862-570-99, 65862-570-10, 65862-571-90, 65862-571-99, 65862-571-10, 65862-572-90, 65862-572-99, 65862-572-10, 65862-573-90, 65862-573-05 |
| D-1039-2019 | Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90; Lot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020 | 65862-570-30, 65862-570-99, 65862-570-10, 65862-571-90, 65862-571-99, 65862-571-10, 65862-572-90, 65862-572-99, 65862-572-10, 65862-573-90, 65862-573-05 |
What to do — step by step
Check Product Details
Look for the lot numbers 470180008A, 470180014A, 470180016A, or 470180032A on your prescription bottle.
Questions people ask
Is this product safe to use?
The FDA confirmed trace amounts of NDEA in the manufacturing process, but the product is still considered safe for short-term use. Long-term risks are not yet confirmed.
Do I need to stop using this product?
The recall does not require stopping use; however, you should check if your product has the affected lot numbers and contact your doctor if you are unsure.
How can I get a replacement?
The recall notice does not specify any replacement or remedy steps, so you should contact your pharmacy or doctor for guidance.
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-1037-2019 — Aurobindo Pharma Aurobindo Pharma Hello, I own a Aurobindo Pharma that is covered by recall D-1037-2019 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-1037-2019 (December 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1037-2019 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.