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Drug recall · FDA · Published July 9, 2018

Mylan Pharmaceuticals Inc. recalls Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc.

Mylan recalls 100-count Triamterene-Hydrochlorothiazide tablets (37.5mg/25mg) due to subpotent drug levels. Rx-only product with specific lot number and expiration date.

🇺🇸 FDA recall #D-0978-2018DrugMylan ›
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Contact the company & request your remedy

Recalling firmMylan Pharmaceuticals Inc.781 Chestnut Ridge Rd · Morgantown, WV 26505-2730
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

Mylan is recalling 100-count tablets of Triamterene and Hydrochlorothiazide (37.5mg/25mg) because they contain less active drug than intended. This means the medication may not work as prescribed, potentially causing treatment failure. Read more at govinfonow.com/recall/40380-mylan-triamterene-hydrochlorothiazide-tablets-recall-subpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/40380-mylan-triamterene-hydrochlorothiazide-tablets-recall-subpotent-drug-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0978-2018

Cite this page

“Mylan Triamterene-Hydrochlorothiazide Tablets Recall: Subpotent Drug Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40380-mylan-triamterene-hydrochlorothiazide-tablets-recall-subpotent-drug-risk. Based on FDA recall #D-0978-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0978-2018%22&limit=1).

Why it’s dangerous

The tablets contain less active drug than labeled, meaning they may not effectively treat conditions like high blood pressure or fluid retention. This could lead to treatment failure if the medication isn't working properly.

Who’s affected

Prescription patients who have the specific 100-count bottle with lot number 2007979 (expired 11/30/2020) are affected. Patients using this medication for conditions like hypertension or edema are most at risk.

How to tell if you have this one

Check for the 100-count bottle labeled 'Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg' with lot number 2007979 and expiration date 11/30/2020. This product is only available by prescription.

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

What to do — step by step

  1. Check Product Details

    Verify the lot number and expiration date on the bottle to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall is due to subpotent drug levels, meaning the medication may not work as intended. It is not safe to use if it's the affected lot.

How do I know if I have the recalled product?

Look for the 100-count bottle with lot number 2007979 and expiration date 11/30/2020.

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.

Take action

Contact Mylan

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

Subject: Recall D-0978-2018 — Mylan Mylan

Hello,

I own a Mylan that is covered by recall D-0978-2018 from Mylan.

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-0978-2018 (July 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0978-2018 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.
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