Northwind Pharmaceuticals LLC recalls Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN
Northwind Pharmaceuticals recalls Valsartan HCTZ 160/12.5mg tablets due to detected carcinogen impurity in manufacturing. Affected lots: UTB23790003, exp 02/28/2019.
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
Northwind Pharmaceuticals is recalling Valsartan HCTZ 160/12.5mg tablets (30 per bottle) because a carcinogen impurity was found in the drug product. This recall affects patients who have taken these specific tablets, as the impurity could pose a cancer risk. Read more at govinfonow.com/recall/40336-northwind-valsartan-hctz-recall-carcinogen-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40336-northwind-valsartan-hctz-recall-carcinogen-impurity-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1096-2018
Cite this page
“Northwind Valsartan HCTZ Recall: Carcinogen Impurity Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40336-northwind-valsartan-hctz-recall-carcinogen-impurity-risk. Based on FDA recall #D-1096-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1096-2018%22&limit=1).
Why it’s dangerous
The drug product contains a carcinogen impurity that was detected during manufacturing. This impurity could lead to cancer risk when the medication is taken by patients. The impurity was found in the API (active pharmaceutical ingredient) used to make the drug.
Who’s affected
Patients prescribed this medication by a healthcare provider are affected. Those who have taken the recalled tablets (lot UTB23790003, expiring 02/2019) are at risk of potential cancer exposure.
How to tell if you have this one
Check for the product name 'Valsartan HCTZ 160/12.5mg', 30 tablets per bottle, and the lot number UTB23790003. The expiration date is 02/28/2019. This product was repackaged by Northwind Pharmaceuticals in Indianapolis, IN.
- Brand
Northwind 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
Terminated- Distribution
Indiana
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1095-2018 | Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52; Lot: UT48320002, exp 07/31/2018; Lot UT48320003, exp 05/31/2019 | 68 bottles |
| D-1096-2018 | Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52; Lot: UTB23790003, exp 02/28/2019 | 43 bottles |
| D-1097-2018 | Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52; Lot: UT48310002, exp 10/31/2018 | 2 bottles |
| D-1098-2018 | Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52; Lot: UT48100001, exp 9/30/2019 | 14 bottles |
What to do — step by step
Check Product Details
Look for the lot number UTB23790003 and expiration date 02/28/2019 on the bottle.
Questions people ask
Is this product safe to take?
The recall indicates a potential cancer risk due to a detected carcinogen impurity. Patients should not take this specific lot and should contact their healthcare provider.
What should I do if I have this product?
The recall does not specify a remedy, so you should check with your healthcare provider for guidance on next steps.
How can I confirm if I have the recalled product?
Check for the lot number UTB23790003 and expiration date 02/28/2019 on the bottle. This product was repackaged by Northwind Pharmaceuticals in Indianapolis, IN.
Contact Northwind Pharmaceuticals
We’ve drafted a message you can send Northwind Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1096-2018 — Northwind Pharmaceuticals Northwind Pharmaceuticals Hello, I own a Northwind Pharmaceuticals that is covered by recall D-1096-2018 from Northwind 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-1096-2018 (July 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1096-2018 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.