RemedyRepack Inc. recalls Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite
RemedyRepack recalls Valsartan 160mg tablets with potential carcinogen impurity in the manufacturing process. Affected lots have specific expiration dates and NDC numbers. Consumers should contact the manufacturer for details.
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
RemedyRepack is recalling Valsartan 160 mg tablets due to a detected carcinogen impurity in the drug product. This could pose a health risk to patients taking the medication, especially those with long-term use. Read more at govinfonow.com/recall/39740-remedyrepack-valsartan-160mg-tablets-recall-carcinogen-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39740-remedyrepack-valsartan-160mg-tablets-recall-carcinogen-impurity-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1101-2018
Cite this page
“RemedyRepack Valsartan 160mg Tablets Recall: Carcinogen Impurity Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39740-remedyrepack-valsartan-160mg-tablets-recall-carcinogen-impurity-risk. Based on FDA recall #D-1101-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1101-2018%22&limit=1).
Why it’s dangerous
The drug product contains a carcinogen impurity that was detected during manufacturing. This impurity could lead to health risks, particularly with prolonged use of the medication.
Who’s affected
Patients prescribed Valsartan 160 mg tablets by a healthcare provider are affected. Those using the medication for extended periods may be at higher risk due to potential carcinogen exposure.
How to tell if you have this one
Check the product label for the NDC number 61786-0792-19 and expiration dates listed in the recall notice. The affected lots include specific batch numbers with dates up to 05/2019.
- Brand
RemedyRepack- 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
Product was distributed to three customers in FL and VA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1100-2018 | Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19; Lot # B0335344-081717, exp. date 08/2018 Lot # B0363364-110917, exp. date 11/2018 Lot # B0391225-012218, exp. date 01/2019 Lot # B0408458-030618, exp. date 03/2019 Lot # B0384871-010318, exp. date 01/2019 Lot # B0436862-051518, exp. date 05/2019 | 9 bottles of 90 = 810 tablets |
| D-1101-2018 | Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19; Lot # B0335344-081717, exp. date 08/2018 Lot # B0363364-110917, exp. date 11/2018 Lot # B0391225-012218, exp. date 01/2019 Lot # B0408458-030618, exp. date 03/2019 Lot # B0384871-010318, exp. date 01/2019 Lot # B0436862-051518, exp. date 05/2019 | 21 bottles of 90 = 1890 tablets |
| D-1102-2018 | Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19; Lot # B0362988-110917, exp. date 10/2018 Lot # B0432265-050318, exp. date 05/2019 Lot # B0450321-061218, exp. date 06/2019 Lot # B0450322-061218, exp. date 05/2019 Lot # B0408652-030718, exp. date 02/2019 | 36 bottles of 90 = 3240 tablets |
What to do — step by step
Contact Manufacturer
Reach out to RemedyRepack Inc. at 625 Kolter Drive, Suite 4, Indiana, PA 15701 for specific product details and instructions.
Questions people ask
Is this product safe to use?
The recall indicates a potential carcinogen impurity, so it is not safe to use. Consumers should contact the manufacturer for further instructions.
What is the specific hazard of this product?
The product contains a carcinogen impurity detected during manufacturing, which could pose health risks with prolonged use.
How can I check if I have the recalled product?
Check the product label for the NDC number 61786-0792-19 and expiration dates listed in the recall notice.
Contact RemedyRepack
We’ve drafted a message you can send RemedyRepack to request your refund or repair — edit it as you like.
Subject: Recall D-1101-2018 — RemedyRepack RemedyRepack Hello, I own a RemedyRepack that is covered by recall D-1101-2018 from RemedyRepack. 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-1101-2018 (August 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1101-2018 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.