FDA Drug recall · Reported August 12, 2026
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.
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Zydus Pharmaceuticals (USA) Inc recalled Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zy… - a moderate-severity action.
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zy… was recalled by Zydus Pharmaceuticals (USA) Inc in August 12, 2026. Reason: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.. Check the official notice for the remedy. Verify recall #D-0745-2026 with the FDA Drug before acting.
The recall
Zydus Pharmaceuticals (USA) Inc issued this moderate-severity FDA Drug recall-CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity..
- Moderate
- severity level
- Class II
- classification
- August 12, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0745-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0745-2026) was formally reported on August 12, 2026, with the manufacturer initiating the action on August 5, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Zydus Pharmaceuticals (USA) Inc is listed as the recalling firm, operating out of Pennington, NJ. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 1 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,781 children & baby products recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Reason for recall
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0745-2026 |
| Date reported | August 12, 2026 |
| Date initiated | August 5, 2026 |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Firm location | Pennington, NJ |
| Affected scope | Not disclosed |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0745-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026