Use caution Drug recall · FDA · Published December 31, 2018

Aurobindo Recalls Valsartan 40mg Due to Impurity

Aurobindo Pharma recalls specific lots of Valsartan Tablets USP 40 mg due to trace amounts of the impurity NDEA found in the manufacturing process.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1037-2019Drug Aurobindo Pharma ›

Use caution until it’s fixed

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Take action

Contact the company

Recalling firmAurobindo Pharma USA Inc.279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401

✎ GovInfoNow plain-language explainer

Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan Tablets USP 40 mg because FDA analysis confirmed the presence of trace amounts of an impurity called N-nitrosodiethylamine (NDEA). This impurity was found in the active pharmaceutical ingredient used to manufacture the product. The recall covers bottles distributed to major chains throughout the United States. Read more at govinfonow.com/recall/39280-aurobindo-recalls-valsartan-40mg-due-to-impurity.

Source Summary by GovInfoNow · govinfonow.com/recall/39280-aurobindo-recalls-valsartan-40mg-due-to-impurity · Updated October 11, 2026 · FDA enforcement record: FDA #D-1037-2019

Cite this page

“Aurobindo Recalls Valsartan 40mg Due to Impurity.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39280-aurobindo-recalls-valsartan-40mg-due-to-impurity. Based on FDA recall #D-1037-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1037-2019%22&limit=1).

The FDA announced on Dec. 31, 2018, that Aurobindo Pharma USA Inc. voluntarily recalled Valsartan Tablets USP 40 mg due to Good Manufacturing Practice deviations involving the impurity N-nitrosodiethylamine (NDEA).

How to tell if you have it

Brand: Aurobindo Pharma
Product: Valsartan Tablets USP 40 mg, 30 count bottles
NDC: 65862-570-30
Lot Numbers: 470180008A (exp. Feb 2020), 470180014A, 470180016A (exp. Mar 2020), 470180032A (exp. May 2020)
Distributed to major distribution chains throughout the United States

The hazard

FDA analysis confirmed the presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA), in the active pharmaceutical ingredient used to manufacture the product.

Context

GovInfoNow's records show Aurobindo Pharma USA Inc. has 32 other recalls on record since April 9, 2013. Recent brand recalls include a July 23, 2026 recall of 10mg Dicyclomine Capsules due to empty capsules and a May 22, 2025 recall of Acetaminophen Tablets due to brown tablet discoloration risk. Other recent recalls of similar products include an Aug. 5, 2026 Zydus Mirabegron 25mg Tablets Recall for N-Nitroso Impurity Risk and a Jan. 21, 2026 Unichem Bisoprolol/Hydrochlorothiazide Tablets Recall for N-Nitroso Impurity Risk.

How to tell if you have this one

Check your medication bottle for the brand Aurobindo Pharma USA Inc. and the label 'Valsartan Tablets USP 40 mg'. Look for NDC 65862-570-30 and one of the following lot numbers: 470180008A (exp. Feb 2020), 470180014A or 470180016A (exp. Mar 2020), or 470180032A (exp. May 2020).

Brand
Aurobindo Pharma
Category
Drug

FDA recall event · 5 products

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

Based on the official FDA remedy

What to do — step by step

Contact Your Pharmacist
Reach out to your pharmacy or healthcare provider immediately to discuss the recall and determine if your specific prescription is affected.
Do Not Stop Medication Abruptly
Consult your doctor before making any changes to your medication regimen, as stopping blood pressure medication suddenly can be dangerous.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Product was distributed to major distribution chains throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 3 months after the firm started it.

Dec 31, 2018Firm started the recall
Mar 21, 2019FDA classified it Class II
Mar 27, 2019Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the expiration date of the recalled tablets?

The expiration dates range from February 2020 to May 2020 depending on the specific lot number.

What is the NDC number for the recalled product?

The National Drug Code (NDC) is 65862-570-30.

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Link to this recall

<a href="https://govinfonow.com/recall/39280-aurobindo-recalls-valsartan-40mg-due-to-impurity">Aurobindo Recalls Valsartan 40mg Due to Impurity (GovInfoNow)</a>

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 qwen3.6:35b-a3b on October 11, 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.