Prinston Recalls Valsartan 160mg Tablets Due to Specification Failures
Prinston recalls 21,987 bottles of Valsartan 160mg tablets due to failed specifications. Check your lot number and expiration date for details.
Use caution until it’s fixed
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Contact the company
What happened, in plain English
Prinston Pharmaceutical Inc is recalling Valsartan Tablets, USP, 160 mg in 90-count bottles because they failed tablet and capsule specifications. The recall was triggered by a confirmed customer complaint that the tablets were thicker and heavier than expected. This issue affects specific lots distributed nationwide. Read more at govinfonow.com/recall/41039-prinston-recalls-valsartan-160mg-tablets-due-to-specification-failures.
Source Summary by GovInfoNow · govinfonow.com/recall/41039-prinston-recalls-valsartan-160mg-tablets-due-to-specification-failures · Updated October 11, 2026 · FDA enforcement record: FDA #D-0209-2018
Cite this page
“Prinston Recalls Valsartan 160mg Tablets Due to Specification Failures.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41039-prinston-recalls-valsartan-160mg-tablets-due-to-specification-failures. Based on FDA recall #D-0209-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0209-2018%22&limit=1).
Why it’s dangerous
The recalled tablets failed to meet established specifications, specifically being thicker and heavier than required. While the record confirms this physical deviation, it does not explicitly state that this results in a direct safety hazard or injury, but rather a quality control failure.
Who’s affected
Patients who have been prescribed Valsartan Tablets, USP, 160 mg from Prinston Pharmaceutical Inc and purchased them in the USA or Puerto Rico before November 29, 2017. Individuals with these specific bottles are at risk of receiving medication that does not meet standard specifications.
How to tell if you have this one
Look for Valsartan Tablets, USP, 160 mg in 90-count bottles manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. and distributed by Solco Healthcare US, LLC. Check the NDC 43547-369-09 and Lot # 343B17025 with an expiration date of 03/31/19.
- Brand
Prinston Pharmaceutical- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your Valsartan Tablets match the recalled NDC, lot number, and expiration date listed in the record.
Contact Your Pharmacist
Speak with your healthcare provider or pharmacist to determine if you have the affected product and what steps to take next.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) is 43547-369-09.
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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-0209-2018 (November 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0209-2018 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.