CLASS II ONGOING Drug recall · Reported 12 Aug 2026 · FDA Enforcement Report
Mirabegron Extended-Release Tablets, 25 mg recalled
Zydus Pharmaceuticals is recalling Mirabegron Extended-Release Tablets, 25 mg, distributed nationwide in the US. The recall was initiated on 5 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0745-2026
- FDA event ID
- 99563
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Brand
- Mirabegron
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Aug 2026
- FDA classified
- 7 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Bladder & Prostate Medication
Timeline
| 5 Aug 2026 | Recall initiated by company | |
| 7 Aug 2026 | Classified by FDA | +2 days |
| 12 Aug 2026 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Which lots are affected?
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
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| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
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| Drug | CLASS III | traZODONE Hydrochloride Tablets, USP, 100mg recalledTrazodone Hydrochloride | Zydus Pharmaceuticals | Other | Nationwide |