Prinston Recalls Irbesartan/HCTZ Tablets Due to Labeling Errors
Prinston recalls 60 bottles of Irbesartan and Hydrochlorothiazide tablets due to incorrect lot numbers on case labels. Check your medication if you have Lot 327B16002.
Lower-risk recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
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What happened, in plain English
Prinston Pharmaceutical Inc is recalling a small quantity of Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg because the lot number on the outer case label does not match the immediate container. The specific issue involves Lot 327B16002, where the correct lot number appears on the bottle but an incorrect one (327B160012) is printed on the case. This recall affects a limited distribution of 60 bottles sold nationwide. Read more at govinfonow.com/recall/42598-prinston-recalls-irbesartan-hctz-tablets-due-to-labeling-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/42598-prinston-recalls-irbesartan-hctz-tablets-due-to-labeling-errors · Updated October 9, 2026 · FDA enforcement record: FDA #D-1049-2016
Cite this page
“Prinston Recalls Irbesartan/HCTZ Tablets Due to Labeling Errors.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42598-prinston-recalls-irbesartan-hctz-tablets-due-to-labeling-errors. Based on FDA recall #D-1049-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1049-2016%22&limit=1).
Why it’s dangerous
The hazard is a labeling discrepancy where the lot number on the shipping case (327B160012) differs from the lot number on the immediate container (327B16002). This could potentially complicate tracking or identification of the specific batch if someone relies solely on the outer packaging, though the record does not indicate a safety risk to the medication itself.
Who’s affected
Patients who have been prescribed Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg distributed by Solco Healthcare U.S., LLC. The risk is primarily to those who might rely on the incorrect case label for lot identification rather than the bottle itself.
How to tell if you have this one
Check for Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. Look for NDC 43547-331-09 and Lot number 327B16002 on the immediate container. Verify if the outer case label shows an incorrect lot number (327B160012). The product was distributed nationwide.
- Brand
Prinston Pharmaceutical- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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
How many bottles are included in this recall?
The recall involves a total of 60 bottles, which were packaged in 5 cases.
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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-1049-2016 (May 30, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1049-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.