RemedyRepack Inc. recalls Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA
RemedyRepack recalls 320mg/12.5mg Valsartan/HCT: Carcinogen impurity detected in manufacturing. Rx-only tablets with lot # B0383153-122917. Contact for return instructions.
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 90-count Valsartan/HCTZ tablets due to a carcinogen impurity found in the drug product. This poses a risk of cancer exposure through ingestion. Affected patients should stop using the medication and contact the manufacturer for a replacement. Read more at govinfonow.com/recall/40348-remedyrepack-valsartan-hctz-tablets-recall-carcinogen-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40348-remedyrepack-valsartan-hctz-tablets-recall-carcinogen-impurity-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1021-2018
Cite this page
“RemedyRepack Valsartan/HCTZ Tablets Recall: Carcinogen Impurity Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40348-remedyrepack-valsartan-hctz-tablets-recall-carcinogen-impurity-risk. Based on FDA recall #D-1021-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1021-2018%22&limit=1).
Why it’s dangerous
The drug product contains a carcinogen impurity that could cause cancer if ingested. This impurity was detected during manufacturing quality control checks. The risk is present in the medication itself, not due to improper use.
Who’s affected
Patients prescribed this prescription medication are affected. Those with the specific lot number and expiration date are at highest risk.
How to tell if you have this one
Check for the 90-count bottle labeled Valsartan/HCTZ 320mg/12.5 mg. Look for lot number B0383153-122917 and expiration date 12/18.
- Brand
RemedyRepack- Category
Drug
All 2 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 3 medical facilities in Florida.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1020-2018 | Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701; Lot # B0318652-070617; Exp. 07/18 | 4 HDPE 90-count bottles (360 tablets) |
| D-1021-2018 | Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701; Lot # B0383153-122917; Exp. 12/18 | 3 HDPE 90-count bottles (270 tablets) |
What to do — step by step
Stop Using Medication
Immediately stop using the recalled Valsartan/HCTZ tablets if you have them.
Questions people ask
Is this medication safe to take?
The official recall states a carcinogen impurity was detected, so it is not safe to take.
How do I know if I have the recalled product?
Check for the lot number B0383153-122917 and expiration date 12/18 on the 90-count bottle.
What should I do if I have the recalled product?
Contact RemedyRepack at 625 Kolter Drive, Suite 4, Indiana, PA 15701 for a replacement or refund.
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-1021-2018 — RemedyRepack RemedyRepack Hello, I own a RemedyRepack that is covered by recall D-1021-2018 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.
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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-1021-2018 (July 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1021-2018 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.