Mylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
Mylan Pharmaceuticals is recalling Mycophenolate Mofetil for injection because it failed to meet dissolution specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is reasonably likely to cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Mylan Pharmaceuticals Inc is recalling 11,336 units of Mycophenolate Mofetil for injection, USP, 500 mg/vial. The product is distributed nationwide in the United States. The recall involves two specific lots: Lot 3242616 with an expiration date of April 2027, and Lot 8220216 with an expiration date of November 2027.
The recall was initiated because the product failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the expected rate when administered. Failure to meet these specifications may result in the drug not being absorbed properly by the body, potentially leading to reduced therapeutic efficacy.
Healthcare providers and patients should check their inventory for the affected NDC numbers (67457-386-00 and 67457-386-81) and lot numbers listed above. If you have this product, do not use it and contact your healthcare provider or the recalling firm for instructions on return or replacement.
The recalled product
- Product
- MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)
- Brand
- MYCOPHENOLATE MOFETIL
- Manufacturer
- Mylan Pharmaceuticals Inc
- Category
- Drug — Prescription Injection
- Affected units
- 11,336
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 (4)
- Lot: 3242616
- Exp. April 2027
- 8220216
- Exp. Nov 2027
Distribution
Distributed nationwide across the United States.
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