Mirabegron Extended-Release Tablets recall
FDA recall D-0745-2026 · initiated Aug 5, 2026
Zydus Pharmaceuticals (USA) Inc recalled Mirabegron Extended-Release Tablets in Aug 2026 — an FDA Class II recall (D-0745-2026) because CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.
- Recalling company
- Zydus Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Aug 5, 2026
- FDA report date
- Aug 12, 2026
Frequently asked
- Was Mirabegron Extended-Release Tablets recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Mirabegron Extended-Release Tablets in Aug 2026 — an FDA Class II recall (D-0745-2026) because CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Mirabegron Extended-Release Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0745-2026 was: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Is a recalled Mirabegron Extended-Release Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Mirabegron Extended-Release Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0745-2026.