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Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only Recall 2026

MIRABEGRONIssued August 5, 2026Updated Reviewed by the Recall Watch editorial team

MIRABEGRON 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, — recalled per FDA on 8/5/2026. Reason: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity..

Agency
FDA
Issued
Aug 5, 2026
Brand
MIRABEGRON
Distribution
1 states
Lots affected
3
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued August 5, 2026 · Last synced Nov 1, 2026

What's recalled

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.

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Why it was recalled

CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

Affected products & lot numbers
3 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot # E408618
Expiry: 11/30/2026
NDC #: 70710-1159-3
Where was it sold
1 state

Nationwide in the USA

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the MIRABEGRON recall still active?

Yes, this recall is currently active as of August 5, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3. Check the label on your product.

What should I do if I have the recalled MIRABEGRON?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.