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.
USMirabegron 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 Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall / Hazard
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Pennington |
| State | NJ |
| Openfda › Nui › 1 | N0000185008 |
| Openfda › Nui › 2 | N0000185007 |
| Openfda › Nui › 3 | N0000182137 |
| Openfda › Nui › 4 | N0000190114 |
| Openfda › Nui › 5 | N0000185503 |
| Openfda › Unii | MVR3JL3B2V |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1300791 |
| Openfda › Rxcui › 2 | 1300801 |
| Openfda › Spl id | df34c0c9-8528-4fd6-a408-e1d44da0f156 |
| Openfda › Brand name | MIRABEGRON |
| Openfda › Spl set id | 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2 |
| Openfda › Package ndc › 1 | 70710-1159-3 |
| Openfda › Package ndc › 2 | 70710-1159-9 |
| Openfda › Package ndc › 3 | 70710-1159-1 |
| Openfda › Package ndc › 4 | 70710-1160-3 |
| Openfda › Package ndc › 5 | 70710-1160-9 |
| Openfda › Package ndc › 6 | 70710-1160-1 |
| Openfda › Product ndc › 1 | 70710-1159 |
| Openfda › Product ndc › 2 | 70710-1160 |
| Openfda › Generic name | MIRABEGRON |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | MIRABEGRON |
| Openfda › Pharm class epc | beta3-Adrenergic Agonist [EPC] |
| Openfda › Pharm class moa › 1 | Adrenergic beta3-Agonists [MoA] |
| Openfda › Pharm class moa › 2 | Cytochrome P450 2D6 Inhibitors [MoA] |
| Openfda › Pharm class moa › 3 | Cytochrome P450 3A Inhibitors [MoA] |
| Openfda › Pharm class moa › 4 | P-Glycoprotein Inhibitors [MoA] |
| Openfda › Manufacturer name | Zydus Pharmaceuticals (USA) Inc. |
| Openfda › Application number | ANDA209488 |
| Openfda › Is original packager | true |
| Event id | 99563 |
| Address 1 | 73 Route 31 N |
| Code info | Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3 |
| Postal code | 08534-3601 |
| Report date | 20260812 |
| Product type | Drugs |
| Reason for recall | CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260805 |
| Initial firm notification | Letter |
| Center classification date | 20260807 |
Check Other Products In Your Household
Free Safety ToolsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Overview
- Recalling FirmZydus Pharmaceuticals (USA) Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA
📢 Share Warning
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Zydus Pharmaceuticals (USA) Inc - 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. Check if your household is affected: https://therecallfile.com/recalls/mirabegron-extended-release-tablets-25-mg-30-count-bottle-rx-only-manu/FDA-D-0745-2026
Join Alertlist
Get instant email updates whenever critical safety recalls like this are published.
Featured on Product Hunt
Help support our public safety mission and check out our community launch.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Related Recalls
UKMHRA Safety Roundup: August 2026
MHRA Safety Roundup: August 2026
Summary of the latest safety advice for medicines and medical device users...
AustraliaCAROTONE skin-brightening products found to contain undeclared prescription-only medicine
CAROTONE skin-brightening products found to contain undeclared prescription-only medicine
We are advising consumers that CAROTONE products marketed for skin brightening may pose a serious risk to your health and should not be used....
UKClass 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles....