Zydus Mirabegron 25mg Tablets Recall: N-Nitroso Impurity Risk
Zydus Pharmaceuticals recalls 25mg Mirabegron Extended-Release Tablets due to N-Nitroso impurity found in some batches. This may pose a risk to health. Affected products have specific lot numbers and expiration dates.
Recall notice
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
What happened, in plain English
Zydus Pharmaceuticals is recalling 25mg Mirabegron Extended-Release Tablets because a chemical impurity was found in some batches. This impurity could potentially pose a health risk to users. Read more at govinfonow.com/recall/309272-zydus-mirabegron-25mg-tablets-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/309272-zydus-mirabegron-25mg-tablets-recall-n-nitroso-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0745-2026
Cite this page
“Zydus Mirabegron 25mg Tablets Recall: N-Nitroso Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/309272-zydus-mirabegron-25mg-tablets-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0745-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0745-2026%22&limit=1).
Why it’s dangerous
The recall is due to a chemical impurity called N-Nitroso Mirabegron found in some batches. This impurity may pose a health risk, though the exact nature of the risk is not specified in the recall notice.
Who’s affected
People with a prescription for Mirabegron Extended-Release Tablets who received this specific batch from Zydus Pharmaceuticals (USA) Inc. Those with the lot number E408618 and expiration date 11/30/2026 are most at risk.
How to tell if you have this one
Check for the product name 'Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle' with lot number E408618 and expiration date 11/30/2026. The NDC number is 70710-1159-3.
- Brand
Zydus Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the product label to confirm if it matches E408618 and 11/30/2026.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 7 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
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-0745-2026 (August 5, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0745-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.