Aurobindo Pharma USA Inc. recalls Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ
Aurobindo Pharma recalls 320mg Valsartan tablets with NDEA impurity above safe levels. FDA confirmed impurity in API used for manufacturing. Stop using immediately if you have these specific lots.
Stop using this now
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Contact the company & request your remedy
What happened, in plain English
Aurobindo Pharma is recalling 320mg Valsartan tablets that contain a harmful impurity (NDEA) above safe levels. This impurity could pose a health risk with long-term use, so affected users should stop using the product immediately. Read more at govinfonow.com/recall/39278-aurobindo-pharma-valsartan-tablets-recall-ndea-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39278-aurobindo-pharma-valsartan-tablets-recall-ndea-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0370-2019
Cite this page
“Aurobindo Pharma Valsartan Tablets Recall: NDEA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39278-aurobindo-pharma-valsartan-tablets-recall-ndea-impurity-risk. Based on FDA recall #D-0370-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0370-2019%22&limit=1).
Why it’s dangerous
The FDA found an impurity called NDEA in the manufacturing process that exceeds safe levels. This impurity could potentially cause health issues with long-term use, especially for people taking the medication regularly.
Who’s affected
People who have the specific 320mg Valsartan tablets with lot numbers VUSD17008-A (exp. 07/2019) or VUSD17009-A (exp. 09/2019) are affected. Those taking this medication for blood pressure should stop using it immediately.
How to tell if you have this one
Check for the product name 'Valsartan tablets USP 320 mg, 90-count bottles, Rx Only' with lot numbers VUSD17008-A (exp. 07/2019) or VUSD17009-A (exp. 09/2019).
- Brand
Aurobindo Pharma- Category
Drug
All 10 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 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0361-2019 | Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30; Lot # VESA17013-A, exp. 10/2019 Lot # VESA17014-A, exp. 10/2019 Lot # VESA18001-A, exp. 12/2019 Lot # VESA18002-A, exp. 12/2019 | 18,408 bottles | 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-0362-2019 | Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.; Lot # VFSA17008-A, exp. 10/2019 Lot # VFSA17010-A, exp. 10/2019 Lot # VFSA18002-A, exp. 01/2020 Lot# VFSA18003-A, exp. 01/2020 Lot # VFSA18007-A, exp. 03/2020 Lot # VFSA18008-A, exp. 03/2020 Lot # VKSA17008-A, exp. 05/2019 Lot # VFSA17009-A, exp. 10/2019 Lot # VKSA17014-A, exp. 10/2019 Lot # VKSA17015-A, exp. 10/2019 Lot # VKSA17016-A, exp. 10/2019 Lot # VKSA17017-A, exp. 10/2019 Lot # VKSA18002-A, exp. 01/2020 Lot # VKSA18004-A, exp. 01/2020 | 60,417 bottles | 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-0363-2019 | Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.; Lot # VMSA17012-A, exp. date 11/2019 Lot # VMSA17013-A, exp. date 11/2019 Lot # VMSA17014-A, exp. date 11/2019 Lot # VMSA17015-A, exp. date 11/2019 Lot # VMSA17016-A, exp. date 11/2019 Lot # VMSA17017-A, exp. date 11/2019 | 27,688 bottles | 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-0364-2019 | Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.; Lot # VKSA18005-A, exp. date 03/2020 Lot # VKSA18001-A, exp. date 01/2020 | 55,788 bottles | 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-0365-2019 | Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.; Lot # HRSA17033-A, exp. date 10/2020 Lot # HRSA17034-A, exp. date 10/2020 Lot # HRSA17035-A, exp. date 10/2020 Lot # HRSA17036-A, exp. date 10/2020 Lot # HRSA17037-A, exp. date 10/2020 | 23,016 bottles | 65862-547-90, 65862-547-99, 65862-547-10, 65862-548-90, 65862-548-99, 65862-548-10, 65862-549-90, 65862-549-99, 65862-549-10, 65862-550-90, 65862-550-05, 65862-551-90, 65862-551-05 |
| D-0366-2019 | Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.; Lot # HTSA17033-A, exp. date 10/2020 Lot # HTSA17034-A, exp. date 10/2020 Lot # HTSA17035-A, exp. date 10/2020 Lot # HTSA17036-A, exp. date 10/2020 Lot # HTSA17040-A, exp. date 10/2020 Lot # HTSA17041-A, exp. date 11/2020 Lot # HTSA17042-A, exp. date 11/2020 Lot # HTSA17043-A, exp. date 11/2020 Lot # HTSA17037-A, exp. date 10/2020 Lot # HTSA17039-A, exp. date 10/2020 | 92,616 bottles | 65862-547-90, 65862-547-99, 65862-547-10, 65862-548-90, 65862-548-99, 65862-548-10, 65862-549-90, 65862-549-99, 65862-549-10, 65862-550-90, 65862-550-05, 65862-551-90, 65862-551-05 |
| D-0367-2019 | Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.; Lot # HTSB17049-A, exp. date 08/2020 Lot # HTSB17054-A, exp. date 10/2020 Lot # HTSB17055-A, exp. date 10/2020 Lot # HTSB17056-A, exp. date 10/2020 Lot # HTSB17057-A, exp. date 10/2020 Lot # HTSB17058-A, exp. date 10/2020 Lot # HTSB17059-A, exp. date 10/2020 Lot # HTSB17060-A, exp. date 10/2020 Lot # HTSB17062-A, exp. date 10/2020 Lot # HTSB17066-A, exp. date 10/2020 Lot # HTSB17067-A, exp. date 11/2020 Lot # HTSB17068-A, exp. date 11/2020 Lot # HTSB17069-A, exp. date 11/2020 Lot # HTSB18001-A, exp. date 12/2020 Lot # HTSB18002-A, exp. date 12/2020 Lot # HTSB18003-A, exp. date 12/2020 Lot # HTSB18004-A, exp. date 12/2020 Lot # HTSB18005-A, exp. date 12/2020 Lot # HTSB18006-A, exp. date 12/2020 Lot # HTSB18007-A, exp. date 12/2020 Lot # HTSB17063-A, exp. date 10/2020 Lot # HTSB17064-A, exp. date 10/2020 Lot # HTSB17065-A, exp. date 10/2020 Lot # HTSB18029-A, exp. date 03/2021 | 111,239 bottles | 65862-547-90, 65862-547-99, 65862-547-10, 65862-548-90, 65862-548-99, 65862-548-10, 65862-549-90, 65862-549-99, 65862-549-10, 65862-550-90, 65862-550-05, 65862-551-90, 65862-551-05 |
| D-0368-2019 | Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.; Lot # HVSA17011-A, exp. date 11/2020 Lot # HVSA17012-A, exp. date 11/2020 Lot # HVSA18001-A, exp. date 12/2020 | 32,160 bottles | 65862-547-90, 65862-547-99, 65862-547-10, 65862-548-90, 65862-548-99, 65862-548-10, 65862-549-90, 65862-549-99, 65862-549-10, 65862-550-90, 65862-550-05, 65862-551-90, 65862-551-05 |
| D-0369-2019 | Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.; Lot # HVSB17023-A, exp. date 08/2020 Lot # HVSB17036-A, exp. date 11/2020 Lot # HVSB17037-A, exp. date 11/2020 Lot # HVSB17038-A, exp. date 11/2020 Lot # HVSB17039-A, exp. date 11/2020 Lot # HVSB17040-B, exp. date 11/2020 Lot # HVSB18001-A, exp. date 12/2020 Lot # HVSB18002-A, exp. date 12/2020 Lot # HVSB18003-A, exp. date 12/2020 Lot # HVSB18004-A, exp. date 12/2020 | 53,064 bottles | 65862-547-90, 65862-547-99, 65862-547-10, 65862-548-90, 65862-548-99, 65862-548-10, 65862-549-90, 65862-549-99, 65862-549-10, 65862-550-90, 65862-550-05, 65862-551-90, 65862-551-05 |
| D-0370-2019 | Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.; Lot # VUSD17008-A, exp. date 07/2019 Lot # VUSD17009-A, exp. date 09/2019 | 20,604 bottles | 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
Stop Using Immediately
Discontinue use of the recalled Valsartan tablets if you have the specific lot numbers mentioned in the recall.
Questions people ask
Is this product safe to use?
No, the FDA confirmed the presence of NDEA impurity above safe levels in this specific batch of Valsartan tablets.
What should I do if I have the recalled product?
Stop using the product immediately and contact your doctor for alternative treatment options.
How can I check if my product is recalled?
Check the lot number on the bottle; the recalled products have lot numbers VUSD17008-A (exp. 07/2019) or VUSD17009-A (exp. 09/2019).
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-0370-2019 — Aurobindo Pharma Aurobindo Pharma Hello, I own a Aurobindo Pharma that is covered by recall D-0370-2019 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-0370-2019 (December 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0370-2019 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.