Rising Pharmaceuticals, Inc. recalls Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ,
Rising Pharmaceuticals recalls 40mg Valsartan tablets due to trace NDEA impurity found in some batches. Consumers should contact the manufacturer for details on affected lots.
Lower-risk recall
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Contact the company & request your remedy
What happened, in plain English
Rising Pharmaceuticals is recalling 40mg Valsartan tablets that may contain a trace amount of NDEA, a potential carcinogen. This recall is due to manufacturing deviations that could pose a health risk. Read more at govinfonow.com/recall/39119-rising-pharmaceuticals-valsartan-tablets-40mg-recall-trace-ndea-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39119-rising-pharmaceuticals-valsartan-tablets-40mg-recall-trace-ndea-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1052-2019
Cite this page
“Rising Pharmaceuticals Valsartan Tablets 40mg Recall: Trace NDEA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39119-rising-pharmaceuticals-valsartan-tablets-40mg-recall-trace-ndea-impurity-risk. Based on FDA recall #D-1052-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1052-2019%22&limit=1).
Why it’s dangerous
The recall involves a trace amount of NDEA, a chemical linked to cancer risk, found in some batches of the medication. This impurity resulted from manufacturing deviations that could affect product safety.
Who’s affected
People who have received the recalled Valsartan tablets from Rising Pharmaceuticals or Acetris Health. Those with specific medical conditions requiring this medication are most at risk.
How to tell if you have this one
Check for Valsartan Tablets 40mg USP, 30 tablets, with NDC numbers 52343-122-30, 470170038A, 470180010A, or 470180012A. The products were distributed by Acetris Health, LLC in Saddle Brook, NJ.
- Brand
Rising Pharmaceuticals- Category
Drug
All 4 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 6 major distributors who may have further distributed the product throughout the United States.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1052-2019 | Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30; 470170038A, exp. date 10/31/2019 470180010A, exp. date 02/29/2019 470180012A, exp. date 03/31/2020 | 30,530 bottles |
| D-1053-2019 | Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90; 471170019A, exp. date 10/31/2019 471180006A, exp. date 03/31/2020 471180007A, exp. date 03/31/2020 471180016A, exp. date 05/31/2020 | 37,410 bottles |
| D-1054-2019 | Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 ---- NDC 52343-124-90; 472180005B, exp. date 02/29/2020 472180011A, exp. date 04/30/2020 472180012A, exp. date 04/30/2020 | 35,281 bottles |
| D-1055-2019 | Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-125-90; 473180007A, exp. date 03/31/2020 473180008A, exp. date 03/31/2020 473180011A, exp. date 04/30/2020 473180020B1, exp. date 07/31/2020 473170019B, exp. date 10/31/2019 | 42,016 bottles |
What to do — step by step
Contact Manufacturer
Reach out to Rising Pharmaceuticals for specific details about affected lots and instructions.
Questions people ask
Is this product safe to use?
The recall indicates a potential risk due to trace NDEA impurity, but the product is not safe to use without verification from the manufacturer.
How can I check if I have the recalled product?
Look for the NDC numbers 52343-122-30, 470170038A, 470180010A, or 470180012A on the product label.
What should I do if I have the recalled product?
Contact Rising Pharmaceuticals directly for instructions on how to handle the product.
Contact Rising Pharmaceuticals
We’ve drafted a message you can send Rising Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1052-2019 — Rising Pharmaceuticals Rising Pharmaceuticals Hello, I own a Rising Pharmaceuticals that is covered by recall D-1052-2019 from Rising Pharmaceuticals. 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.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-1052-2019 (March 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1052-2019 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.