Mylan Pharmaceuticals Inc. recalls Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan
Mylan recalls 100-count Maxzide-25 tablets (37.5mg/25mg) due to slightly elevated drug levels in routine testing. This may cause higher than intended drug effects.
Lower-risk recall
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 100-count Maxzide-25 tablets (37.5mg/25mg) because routine testing showed slightly higher drug levels than expected. This could lead to stronger medication effects than intended. Read more at govinfonow.com/recall/40497-mylan-maxzide-25-tablets-recall-superpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40497-mylan-maxzide-25-tablets-recall-superpotent-drug-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0877-2018
Cite this page
“Mylan Maxzide-25 Tablets Recall: Superpotent Drug Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40497-mylan-maxzide-25-tablets-recall-superpotent-drug-risk. Based on FDA recall #D-0877-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0877-2018%22&limit=1).
Why it’s dangerous
The testing found slightly higher levels of the active ingredients than normal. This could mean the medication has a stronger effect than intended, potentially causing side effects like dizziness or rapid heartbeat.
Who’s affected
People prescribed Maxzide-25 by a doctor who have the specific 100-count bottle with NDC 0378-0464-01. Those taking the medication for conditions like high blood pressure are most at risk.
How to tell if you have this one
Check for the 100-count bottle labeled 'Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/25 mg'. The NDC code is 0378-0464-01. This product is prescription-only.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Medication Details
Verify the product label matches the recalled version: 100-count bottle with NDC 0378-0464-01.
Questions people ask
Is this product safe to use?
The recall is for slightly elevated drug levels, which may cause stronger effects than intended. Consult your doctor before using.
How can I tell if I have the recalled product?
Look for the 100-count bottle labeled 'Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/25 mg' with NDC 0378-0464-01.
Do I need to stop using this medication?
The recall does not require stopping use; consult your doctor for guidance on whether to continue taking it.
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-0877-2018 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0877-2018 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-0877-2018 (June 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0877-2018 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.