Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only,
Prinston Pharmaceutical recalls Solco Healthcare US Valsartan and Hydrochlorothiazide 160mg/25mg tablets due to detected carcinogen impurity in manufacturing. Affected products include 90-count bottles with NDC 43547-313-09.
Lower-risk recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Contact the company & request your remedy
What happened, in plain English
Prinston Pharmaceutical is recalling Solco Healthcare's Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was found in the drug product. This recall affects prescription-only 90-count bottles manufactured by a Chinese company and distributed in the US. The impurity poses a cancer risk if the drug is taken long-term. Read more at govinfonow.com/recall/40366-prinston-solco-healthcare-valsartan-hydrochlorothiazide-tablets-recall-carcinogen-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40366-prinston-solco-healthcare-valsartan-hydrochlorothiazide-tablets-recall-carcinogen-impurity-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0974-2018
Cite this page
“Prinston Solco Healthcare Valsartan-Hydrochlorothiazide Tablets Recall: Carcinogen Impurity Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40366-prinston-solco-healthcare-valsartan-hydrochlorothiazide-tablets-recall-carcinogen-impurity-risk. 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 drug product contains a carcinogen impurity that was detected during manufacturing. This impurity could potentially increase cancer risk if the medication is taken over time. The impurity was found in the active pharmaceutical ingredient used to make the tablets.
Who’s affected
Prescription patients who have the 90-count bottle of Solco Healthcare Valsartan and Hydrochlorothiazide tablets (160mg/25mg) with NDC 43547-313-09. Patients on blood pressure medication who take this specific combination are most at risk.
How to tell if you have this one
Look for the 90-count bottle labeled 'Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets'. The product has NDC code 43547-313-09 and was distributed by Solco Healthcare US, LLC in the US.
- Brand
Prinston Pharmaceutical- Category
Drug
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 number | Product, codes & lots | NDC |
|---|---|---|
| D-0968-2018 | Solco 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-0969-2018 | Solco 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-0970-2018 | Solco 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-0971-2018 | Solco 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-0972-2018 | Solco 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-0973-2018 | Solco 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-0974-2018 | Solco 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 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-0975-2018 | Solco 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-0976-2018 | Solco 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 |
What to do — step by step
Check Product Details
Verify the product label shows 'Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets' with NDC 43547-313-09.
Questions people ask
Is this product safe to take?
The recall states a carcinogen impurity was detected in the manufacturing process, but the product is not safe for long-term use due to potential cancer risk.
How do I know if I have the recalled product?
Check for the 90-count bottle with NDC code 43547-313-09, manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. in China and distributed by Solco Healthcare US, LLC.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance on safe alternatives.
Contact Prinston Pharmaceutical
We’ve drafted a message you can send Prinston Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0974-2018 — Prinston Pharmaceutical Prinston Pharmaceutical Hello, I own a Prinston Pharmaceutical that is covered by recall D-0974-2018 from Prinston Pharmaceutical. 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-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 qwen3:4b 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.