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Drug recall · FDA · Published April 6, 2018

Sandoz Incorporated recalls Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz,

Sandoz recalls 75mg/50mg Triamterene-Hydrochlorothiazide tablets due to cross contamination with unrelated ingredients like Lisinopril and Mannitol. Affected products were sold in 500-count bottles with specific lot numbers.

🇺🇸 FDA recall #D-0631-2018DrugSandoz ›
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Contact the company & request your remedy

Recalling firmSandoz Incorporated2555 W Midway Blvd · Broomfield, CO 80020-1632
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Sandoz is recalling 75mg/50mg Triamterene-Hydrochlorothiazide tablets that may contain traces of other medications. This cross-contamination could cause unintended medication interactions if taken by people with specific health conditions. Read more at govinfonow.com/recall/40627-sandoz-triamterene-hydrochlorothiazide-tablets-recall-cross-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/40627-sandoz-triamterene-hydrochlorothiazide-tablets-recall-cross-contamination-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0631-2018

Cite this page

“Sandoz Triamterene-Hydrochlorothiazide Tablets Recall: Cross Contamination Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40627-sandoz-triamterene-hydrochlorothiazide-tablets-recall-cross-contamination-risk. Based on FDA recall #D-0631-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0631-2018%22&limit=1).

Why it’s dangerous

The tablets may contain traces of unrelated medications such as Lisinopril, Mannitol, Iron, Calcium, and Phosphorous. These substances could interact with other medications or health conditions, potentially causing unintended effects.

Who’s affected

People prescribed this medication by a doctor are affected. Those with conditions requiring strict medication purity, like kidney issues or heart problems, are at higher risk.

How to tell if you have this one

Check for 500-count bottles labeled 'Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg'. The lot numbers GW8264 and HD3095 with expiration date 12/18 are affected.

  • Brand
    Sandoz
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product label for the specific lot numbers GW8264 or HD3095 with expiration date 12/18.

✎ GovInfoNow

Questions people ask

Is this product safe to take?

The recall does not state that the product is safe to take. Cross contamination with unrelated ingredients may cause unintended medication interactions.

What should I do if I have this product?

The recall record does not specify a remedy, so no action is required beyond checking if you have the affected lot numbers.

How can I confirm if my product is affected?

Check the product label for lot numbers GW8264 or HD3095 with expiration date 12/18.

Take action

Contact Sandoz

We’ve drafted a message you can send Sandoz to request your refund or repair — edit it as you like.

Subject: Recall D-0631-2018 — Sandoz Sandoz

Hello,

I own a Sandoz that is covered by recall D-0631-2018 from Sandoz.

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-0631-2018 (April 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0631-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on October 7, 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