NuCare Pharmaceuticals Inc recalls Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC
NuCare Pharmaceuticals recalls 320/25mg Valsartan/HCTZ tablets due to detected carcinogen impurity in manufacturing. This may pose cancer risk. Check your prescription label for NDC 68071-4183-3.
Recall notice
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Contact the company & request your remedy
What happened, in plain English
NuCare Pharmaceuticals is recalling 320/25mg Valsartan/HCTZ tablets because a carcinogen was found in the manufacturing process. This could increase cancer risk for people taking the medication. Read more at govinfonow.com/recall/39836-nucare-valsartan-hctz-tablets-recall-carcinogen-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39836-nucare-valsartan-hctz-tablets-recall-carcinogen-impurity-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1039-2018
Cite this page
“NuCare Valsartan/HCTZ Tablets Recall: Carcinogen Impurity Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39836-nucare-valsartan-hctz-tablets-recall-carcinogen-impurity-risk. Based on FDA recall #D-1039-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1039-2018%22&limit=1).
Why it’s dangerous
The recall is for a carcinogen impurity detected in the active pharmaceutical ingredient used to make the drug. This impurity could potentially increase cancer risk over time when taken regularly.
Who’s affected
People with a prescription for these specific tablets are affected. Those taking the medication for blood pressure or other conditions may be at risk.
How to tell if you have this one
Check your prescription label for the product name 'Valsartan/HCTZ 320/25mg Tablets', 30-count jar, Rx Only. Look for NDC 68071-4183-3 and lot number T11577.
- Brand
NuCare Pharmaceuticals- Category
Drug
All 3 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
Terminated- Distribution
Distributed to three customers in Fl and CA
| Recall number | Product, codes & lots |
|---|---|
| D-1037-2018 | Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9; Lot # U01779; Exp. 04/30/2019 |
| D-1038-2018 | Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,; Lot # T11443; Exp. 02/28/2019 |
| D-1039-2018 | Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3; Lot # T11577; Exp. 06/30/2019 |
What to do — step by step
Check Your Prescription Label
Look for the product name 'Valsartan/HCTZ 320/25mg Tablets', 30-count jar, Rx Only, NDC 68071-4183-3, and lot number T11577.
Questions people ask
Is this product safe to take?
The recall states a carcinogen impurity was detected in the manufacturing process, but the official notice does not specify if the product is safe to take.
How can I check if I have the recalled product?
Check your prescription label for the product name 'Valsartan/HCTZ 320/25mg Tablets', 30-count jar, Rx Only, NDC 68071-4183-3, and lot number T11577.
What should I do if I have the recalled product?
The recall notice does not specify a remedy, so the official notice does not say what to do next.
Contact NuCare Pharmaceuticals
We’ve drafted a message you can send NuCare Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1039-2018 — NuCare Pharmaceuticals NuCare Pharmaceuticals Hello, I own a NuCare Pharmaceuticals that is covered by recall D-1039-2018 from NuCare 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.
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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-1039-2018 (July 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1039-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.