American Health Packaging recalls Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by:
American Health Packaging recalls Valsartan Tablets USP 160 mg due to detected NDEA, a carcinogen impurity in the active ingredient. Affected lots include Mar 2020 batch 179791.
Recall notice
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
American Health Packaging is recalling Valsartan Tablets USP 160 mg because they contain NDEA, a carcinogen impurity. This poses a cancer risk with long-term use. The recall affects specific lots manufactured in March 2020. Read more at govinfonow.com/recall/39125-american-health-packaging-valsartan-tablets-recall-ndea-carcinogen-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/39125-american-health-packaging-valsartan-tablets-recall-ndea-carcinogen-impurity · Updated October 5, 2026 · FDA enforcement record: FDA #D-1047-2019
Cite this page
“American Health Packaging Valsartan Tablets Recall: NDEA Carcinogen Impurity.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39125-american-health-packaging-valsartan-tablets-recall-ndea-carcinogen-impurity. Based on FDA recall #D-1047-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1047-2019%22&limit=1).
Why it’s dangerous
NDEA is a known carcinogen that can cause cancer with long-term exposure. The presence of this impurity in the active ingredient means the medication may contain harmful levels of the carcinogen.
Who’s affected
People who have the specific Valsartan Tablets USP 160 mg lot 179791 (March 2020) are affected. Those using prescription blood pressure medication are most at risk.
How to tell if you have this one
Check for the lot number 179791 on the packaging from March 2020. The product is labeled as Valsartan Tablets USP 160 mg, 100 tablets per unit dose blister.
- Brand
American Health Packaging- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 179791 on the packaging from March 2020.
Questions people ask
Is this product safe to use?
The recall states the presence of NDEA, a carcinogen impurity, so it is not safe for long-term use.
What should I do if I have this product?
The recall does not specify a remedy, so contact American Health Packaging for guidance.
How can I confirm if my product is affected?
Check the lot number 179791 on the packaging from March 2020.
Contact American Health Packaging
We’ve drafted a message you can send American Health Packaging to request your refund or repair — edit it as you like.
Subject: Recall D-1047-2019 — American Health Packaging American Health Packaging Hello, I own a American Health Packaging that is covered by recall D-1047-2019 from American Health Packaging. 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-1047-2019 (March 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1047-2019 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.