FDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
Zydus Pharmaceuticals is recalling Mirabegron extended-release tablets, 25 mg, due to an out-of-specification result for the N-Nitroso Mirabegron impurity. The recall affects nationwide distribution in the USA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a potential nitrosamine impurity, which is a known carcinogen. While no illnesses have been reported, the presence of such impurities in pharmaceutical products warrants a Severe classification per the rubric.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Mirabegron Extended-Release Tablets, 25 mg, packaged in 30-count bottles. The product is an extended-release oral tablet used as a beta3-adrenergic agonist, manufactured by Zydus Lifesciences Ltd. in India and distributed by Zydus Pharmaceuticals (USA) Inc in New Jersey.
The recall was initiated due to an out-of-specification (OOS) result for the N-Nitroso Mirabegron impurity, a potential nitrosamine contaminant. Nitrosamines are a class of impurities that may be carcinogenic and are typically associated with good manufacturing practice (CGMP) deviations.
The recalled product is identified by Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3. Distribution is nationwide in the USA. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should immediately check the lot number and expiration date of any Mirabegron tablets in their possession. Patients currently taking this medication should contact their healthcare provider to discuss alternative treatment options. Any unused product from the recalled lot should be returned to the pharmacy or distributor where it was purchased. For more information, contact Zydus Pharmaceuticals (USA) Inc.
The recalled product
- Product
- MIRABEGRON (MIRABEGRON)
- Brand
- MIRABEGRON
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # E408618
- Expiry: 11/30/2026
- NDC #: 70710-1159-3
Distribution
Distributed nationwide across the United States.
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