Zydus Mirabegron Tablets Recall Due to Impurity
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Zydus Pharmaceuticals (USA) Inc. is recalling one lot of Mirabegron Extended-Release Tablets, 25 mg due to an out-of-specification result for N-Nitroso Mirabegron impurity.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 18, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Zydus Pharmaceuticals (USA) Inc. initiated a voluntary recall due to current good manufacturing practices (CGMP) deviations involving an out-of-specification (OOS) result for N-Nitroso Mirabegron impurity.
Which Products Are Affected
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. Lot # E408618, Expiry: 11/30/2026. Distributed nationwide in the USA. Recall number D-0745-2026. Classification: Class II.
What You Should Do
Consumers should contact their pharmacy or healthcare provider for guidance on the recalled product.
Why This Matters
The recall involves a prescription drug distributed nationwide and classified as Class II by the FDA.
Source
FDA recall D-0745-2026, event ID 99563.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (901 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 18, 2026.
Frequently Asked Questions
Common questions about this FDA recall.