Mylan Recalls Prasugrel Tablets for Failed Dissolution and Stability Testing
Mylan Pharmaceuticals is recalling 47,662 bottles of Prasugrel 10mg tablets because they failed dissolution specifications and 18-month stability testing.
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 due to failed quality specifications (dissolution and stability) without reported injuries or illnesses, fitting the criteria for moderate severity involving potential but not confirmed adverse health consequences.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 47,662 bottles of Prasugrel Tablets, USP, 10mg. The affected product is Lot #3225272 with an expiration date of September 30, 2026. The product was distributed nationwide within the U.S.
The recall was initiated because the product failed to meet dissolution specifications and did not meet 18-month stability testing acceptance criteria. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The product is a prescription medication, so patients should not discontinue therapy without medical advice.
The recalled product
- Product
- PRASUGREL (PRASUGREL)
- Brand
- PRASUGREL
- Manufacturer
- Mylan Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Affected units
- 47,662
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 #: 3225272
- Exp. September 30
- 2026
UPCs (1)
- 0303785185932
Distribution
Distributed nationwide across the United States.
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