Mylan Recalls Blood Pressure Tablets Due to Impurity
Mylan Pharmaceuticals recalls specific lots of Candesartan Cilexetil and Hydrochlorothiazide tablets due to out-of-specification organic impurities.
Use caution until it’s fixed
Out-of-specification organic impurity results obtained during routine stability testing.
Contact the company
What happened, in plain English
Mylan Pharmaceuticals Inc. is recalling specific lots of Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg. The recall was initiated because routine stability testing revealed out-of-specification organic impurities in the product. This affects both 90-count and 500-count bottles distributed nationwide. Read more at govinfonow.com/recall/36756-mylan-recalls-blood-pressure-tablets-due-to-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/36756-mylan-recalls-blood-pressure-tablets-due-to-impurity · Updated October 11, 2026 · FDA enforcement record: FDA #D-0049-2021
Cite this page
“Mylan Recalls Blood Pressure Tablets Due to Impurity.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36756-mylan-recalls-blood-pressure-tablets-due-to-impurity. 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
The tablets contain out-of-specification organic impurities identified during stability testing. While the record does not detail specific health effects, impurities in pharmaceuticals can potentially alter the drug's safety or efficacy profile compared to the labeled standard.
Who’s affected
Patients who have been prescribed or purchased Candesartan Cilexetil and Hydrochlorothiazide Tablets from Mylan Pharmaceuticals Inc. between the manufacturing dates and expiration dates listed in the record. Individuals with these specific lot numbers are at risk of consuming medication that does not meet purity specifications.
How to tell if you have this one
Check your medication bottle for the following details: Product is Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg. Look for NDC 0378-3002-77 (90-count bottles) or NDC 0378-3002-05 (500-count bottles). Verify the Lot numbers are either 8095666 or 3104664, both with an expiration date of July 2021.
- Brand
Mylan Pharmaceuticals- Category
Drug
What to do — step by step
Check your medication
Verify if your bottle matches the NDC numbers and lot numbers listed in the recall record.
Contact your pharmacist
Speak with your pharmacy or healthcare provider to determine the appropriate next steps for replacement or disposal, as the remedy is not explicitly stated in this record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 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.
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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 qwen3.6:35b-a3b on October 11, 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.