Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only
Recalled by Zydus Pharmaceuticals (USA) Inc
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Zydus Pharmaceuticals (USA) Inc has recalled Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on August 12, 2026 and was initiated on August 5, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only. The company behind the recall is Zydus Pharmaceuticals (USA) Inc, based in Pennington, NJ. The FDA describes the product as: “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.”
Why was Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only recalled?
According to the FDA, the stated reason for the recall is: “CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.” In plain terms, this recall relates to a manufacturing quality issue (CGMP).
CGMP stands for Current Good Manufacturing Practice — the FDA's quality rules for how medicines must be made, tested, and documented. A CGMP-related recall means the manufacturing process did not meet those standards. It does not automatically mean the medicine is harmful, but the FDA cannot be confident in its quality, so it is removed from the market.
What should you do?
If you think you may have bought Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, compare it against the product description and identifying codes (Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Zydus Pharmaceuticals (USA) Inc or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Who this recall affects
This recall matters to anyone who bought Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: Nationwide in the USA.
What manufacturing quality issue (CGMP) actually means
CGMP stands for Current Good Manufacturing Practice — the FDA's quality rules for how medicines must be made, tested, and documented. A CGMP-related recall means the manufacturing process did not meet those standards. It does not automatically mean the medicine is harmful, but the FDA cannot be confident in its quality, so it is removed from the market.
In this case, the concern applies specifically to Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only from Zydus Pharmaceuticals (USA) Inc — not to the wider category of products. Similar items from other brands aren't part of this recall.
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- August 12, 2026
- Recall started
- August 5, 2026
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only recalled?+
According to the FDA: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0745-2026. Information last synced from the FDA on August 19, 2026.