Prinston Pharmaceutical Inc recalls Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical
Prinston Pharmaceutical recalls 30-count Irbesartan/Hydrochlorothiazide tablets (NDC 43547-331-03) due to FDA-confirmed NDEA impurity exceeding safe levels. Consumers should contact Solco Healthcare for details.
Lower-risk recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Contact the company & request your remedy
What happened, in plain English
Prinston Pharmaceutical is recalling Irbesartan and Hydrochlorothiazide tablets (30-count) because they contain an impurity (NDEA) that exceeds safe levels as confirmed by the FDA. This impurity could pose a health risk with long-term use. Read more at govinfonow.com/recall/39232-prinston-irbesartan-hydrochlorothiazide-tablets-recall-ndea-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39232-prinston-irbesartan-hydrochlorothiazide-tablets-recall-ndea-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0411-2019
Cite this page
“Prinston Irbesartan/Hydrochlorothiazide Tablets Recall: NDEA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39232-prinston-irbesartan-hydrochlorothiazide-tablets-recall-ndea-impurity-risk. Based on FDA recall #D-0411-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0411-2019%22&limit=1).
Why it’s dangerous
The tablets contain N-nitrosodimethylamine (NDEA), a known carcinogen, in amounts above the FDA's acceptable daily intake level. While the impurity is present in small quantities, long-term use could increase cancer risk.
Who’s affected
People who have the 30-count Irbesartan/Hydrochlorothiazide tablets (NDC 43547-331-03) from Prinston Pharmaceutical. Those with high blood pressure or kidney issues may be at greater risk due to medication interactions.
How to tell if you have this one
Check for the 30-count tablets labeled 'Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only' with NDC code 43547-331-03. They were distributed by Solco Healthcare US, LLC.
- Brand
Prinston Pharmaceutical- Category
Drug
All 5 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
Completed- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0409-2019 | Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09; 331B18009 | 19800 bottles | 43547-374-03, 43547-374-09, 43547-374-50, 43547-375-03, 43547-375-09, 43547-375-50, 43547-376-03, 43547-376-09, 43547-376-50 |
| D-0410-2019 | Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-09; 325B18004 | 2177 bottles | 43547-330-03, 43547-330-09, 43547-330-50, 43547-331-03, 43547-331-09, 43547-331-50 |
| D-0411-2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03; 327A18001 327A18002 | 32692 bottles | 43547-330-03, 43547-330-09, 43547-330-50, 43547-331-03, 43547-331-09, 43547-331-50 |
| D-0412-2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 90 count NDC 43547-331-09; 327B18008 327B18009 | 12294 bottles | 43547-330-03, 43547-330-09, 43547-330-50, 43547-331-03, 43547-331-09, 43547-331-50 |
| D-0413-2019 | Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03; 325D18004 325D18005 | 87505 bottles | 43547-330-03, 43547-330-09, 43547-330-50, 43547-331-03, 43547-331-09, 43547-331-50 |
What to do — step by step
Check Product Details
Look for the NDC code 43547-331-03 on the tablet packaging to confirm if it's affected.
Questions people ask
Is this recall dangerous?
The FDA confirmed the presence of NDEA, a potential carcinogen, in levels above the acceptable daily intake. However, the risk is considered low for most users based on current data.
How do I get a replacement?
The recall record does not specify a replacement process. Contact Solco Healthcare US, LLC for details.
Are there any safety risks?
The impurity could pose a long-term cancer risk with repeated use, but the product is not immediately dangerous.
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-0411-2019 — Prinston Pharmaceutical Prinston Pharmaceutical Hello, I own a Prinston Pharmaceutical that is covered by recall D-0411-2019 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.
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-0411-2019 (January 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0411-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.