Mylan Pharmaceuticals Inc. recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC
Mylan recalls 32mg/12.5mg Candesartan Cilexetil and Hydrochlorothiazide tablets with out-of-spec organic impurities found in stability testing. Rx-only bottles from specific lots and expiration dates.
Recall notice
Out-of-specification organic impurity results obtained during routine stability testing.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling certain 32mg/12.5mg blood pressure medication tablets due to organic impurities detected during stability testing. This could potentially affect medication safety, though the recall doesn't specify immediate health risks. Read more at govinfonow.com/recall/36756-mylan-candesartan-cilexetil-and-hydrochlorothiazide-tablets-recall-out-of-spec.
Source Summary by GovInfoNow · govinfonow.com/recall/36756-mylan-candesartan-cilexetil-and-hydrochlorothiazide-tablets-recall-out-of-spec · Updated October 4, 2026 · FDA enforcement record: FDA #D-0049-2021
Cite this page
“Mylan Candesartan Cilexetil and Hydrochlorothiazide Tablets Recall: Out-of-Spec Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36756-mylan-candesartan-cilexetil-and-hydrochlorothiazide-tablets-recall-out-of-spec. Based on FDA recall #D-0049-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0049-2021%22&limit=1).
Why it’s dangerous
Routine stability testing found organic impurities in these tablets that could potentially affect medication safety. The impurities were detected during quality control checks but the exact health risk isn't specified in the recall.
Who’s affected
People with prescriptions for these specific tablet strengths who received the recalled lots (8095666 or 3104664) from the listed expiration dates. Those with blood pressure conditions are most at risk.
How to tell if you have this one
Check for 90-count or 500-count bottles labeled with NDC 0378-3002-77 or 0378-3002-05. The tablets are prescription-only and expire July 2021 (lot 8095666 or 3104664).
- Brand
Mylan- Category
Drug
What to do — step by step
Check Your Medication
Look for the specific NDC numbers and expiration dates listed in the recall notice to confirm if your tablets are affected.
Questions people ask
Are these tablets safe to take?
The recall states organic impurities were found during testing, but does not specify immediate health risks. Consult your doctor for personalized advice.
How can I tell if my tablets are recalled?
Check for NDC numbers 0378-3002-77 (90-count) or 0378-3002-05 (500-count) with expiration dates of July 2021 (lots 8095666 or 3104664).
Do I need to stop using these tablets?
The recall does not specify a stop-use instruction; you should check if your tablets are affected before taking them.
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-0049-2021 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0049-2021 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-0049-2021 (October 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0049-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.