FDA recall, , Moderate risk
Zydus Mirabegron Extended-Release Tablets
Mirabegron Extended-Release Tablets contain an impurity above specification.
Summary by Recall Canary from the FDA notice
What happened
Zydus Pharmaceuticals (USA) Inc, of Pennington, New Jersey, recalled Mirabegron Extended-Release Tablets, 25 mg, 30-count bottles, due to an out of specification result for N-Nitroso Mirabegron impurity. The tablets, manufactured by Zydus Lifesciences Ltd. in Matoda, Ahmedabad, India, and distributed by Zydus Pharmaceuticals (USA) Inc., were distributed nationwide in the USA. The recall began on August 5, 2026, and was added to the FDA's Enforcement Report on August 6, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle
- NDC
- 70710-1159-3
- Lot code
- E408618
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- Zydus Pharmaceuticals (USA) IncPennington, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99563
- Recall number
- D-0745-2026
All recalls from Zydus Pharmaceuticals (USA) Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Classified by FDA · Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
