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Stop using now Drug recall · FDA · Published July 13, 2018

Solco Valsartan/HCTZ Recall: Carcinogen Impurity Found

Prinston Pharma recalls Solco Healthcare US Valsartan and HCTZ tablets due to carcinogen impurity. Check your NDC and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0974-2018DrugSolco Healthcare US ›
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Contact the company

Recalling firmPrinston Pharmaceutical Inc2002 Eastpark Blvd · Cranbury, NJ 08512-3514
✎ GovInfoNow plain-language explainer

What happened, in plain English

Prinston Pharmaceutical Inc is recalling Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets in 90-count bottles. The recall was initiated because a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the drug product. This affects all lots within the expiry date. Read more at govinfonow.com/recall/40366-solco-valsartan-hctz-recall-carcinogen-impurity-found.

Source Summary by GovInfoNow · govinfonow.com/recall/40366-solco-valsartan-hctz-recall-carcinogen-impurity-found · Updated October 11, 2026 · FDA enforcement record: FDA #D-0974-2018

Cite this page

“Solco Valsartan/HCTZ Recall: Carcinogen Impurity Found.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40366-solco-valsartan-hctz-recall-carcinogen-impurity-found. Based on FDA recall #D-0974-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0974-2018%22&limit=1).

Why it’s dangerous

The hazard involves CGMP (Current Good Manufacturing Practice) deviations where a carcinogen impurity was found in the API used to make the drug. Long-term exposure to carcinogens can increase the risk of developing cancer, which is why this is classified as a Class II recall.

Who’s affected

Patients currently taking Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets distributed in the United States. Individuals with prescriptions filled from this specific batch are at risk of exposure to a carcinogen.

How to tell if you have this one

Look for Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets in 90-count bottles. The product is Rx Only and has NDC 43547-313-09. It was manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. in China and distributed by Solco Healthcare US, LLC in Cranbury, NJ. All lots within the expiry date are included.

  • Brand
    Solco Healthcare US
  • Category
    Drug
FDA recall event · 9 products

All 9 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
    Ongoing
  • Distribution
    United States
Recall numberProduct, codes & lotsNDC
D-0968-2018Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03; All lots within expiry.43547-367-03, 43547-367-09, 43547-367-50, 43547-367-11, 43547-368-03, 43547-368-09, 43547-368-50, 43547-368-11, 43547-369-03, 43547-369-09, 43547-369-50, 43547-369-11, 43547-370-03, 43547-370-09, 43547-370-50, 43547-370-11
D-0969-2018Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-368-09; All lots within expiry.43547-367-03, 43547-367-09, 43547-367-50, 43547-367-11, 43547-368-03, 43547-368-09, 43547-368-50, 43547-368-11, 43547-369-03, 43547-369-09, 43547-369-50, 43547-369-11, 43547-370-03, 43547-370-09, 43547-370-50, 43547-370-11
D-0970-2018Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-369-09; All lots within expiry.43547-367-03, 43547-367-09, 43547-367-50, 43547-367-11, 43547-368-03, 43547-368-09, 43547-368-50, 43547-368-11, 43547-369-03, 43547-369-09, 43547-369-50, 43547-369-11, 43547-370-03, 43547-370-09, 43547-370-50, 43547-370-11
D-0971-2018Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-370-09; All lots within expiry.43547-367-03, 43547-367-09, 43547-367-50, 43547-367-11, 43547-368-03, 43547-368-09, 43547-368-50, 43547-368-11, 43547-369-03, 43547-369-09, 43547-369-50, 43547-369-11, 43547-370-03, 43547-370-09, 43547-370-50, 43547-370-11
D-0972-2018Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-311-09; All lots within expiry.43547-311-03, 43547-311-09, 43547-311-50, 43547-312-03, 43547-312-09, 43547-312-50, 43547-313-03, 43547-313-09, 43547-313-50, 43547-314-03, 43547-314-09, 43547-314-50, 43547-315-03, 43547-315-09, 43547-315-50
D-0973-2018Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-312-09; All lots within expiry.43547-311-03, 43547-311-09, 43547-311-50, 43547-312-03, 43547-312-09, 43547-312-50, 43547-313-03, 43547-313-09, 43547-313-50, 43547-314-03, 43547-314-09, 43547-314-50, 43547-315-03, 43547-315-09, 43547-315-50
D-0974-2018Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-313-09; All lots within expiry43547-311-03, 43547-311-09, 43547-311-50, 43547-312-03, 43547-312-09, 43547-312-50, 43547-313-03, 43547-313-09, 43547-313-50, 43547-314-03, 43547-314-09, 43547-314-50, 43547-315-03, 43547-315-09, 43547-315-50
D-0975-2018Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09; All lots within expiry.43547-311-03, 43547-311-09, 43547-311-50, 43547-312-03, 43547-312-09, 43547-312-50, 43547-313-03, 43547-313-09, 43547-313-50, 43547-314-03, 43547-314-09, 43547-314-50, 43547-315-03, 43547-315-09, 43547-315-50
D-0976-2018Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-315-09; All lots within expiry.43547-311-03, 43547-311-09, 43547-311-50, 43547-312-03, 43547-312-09, 43547-312-50, 43547-313-03, 43547-313-09, 43547-313-50, 43547-314-03, 43547-314-09, 43547-314-50, 43547-315-03, 43547-315-09, 43547-315-50
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify if you have Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets with NDC 43547-313-09.

  2. Consult Your Doctor

    Contact your healthcare provider immediately to discuss alternative treatments or next steps, as the remedy details are not specified in the record.

How this recall unfolded

Recall timeline

FDA published this recall 19 days after the firm started it.

1. Firm started the recall: Jul 13, 201812. FDA classified it Class II: Jul 20, 201823. Published in FDA’s Enforcement Report: Aug 1, 201832018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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-0974-2018 (July 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0974-2018 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA