Mylan recalls 5mg Prasugrel tablets with low dissolution risk. Check NDC 0378-5185-93 and lots 3211073-3211075 for affected products.
Failed Dissolution Specifications - low dissolution results
Mylan is recalling Prasugrel 5mg tablets that may not dissolve properly. This could affect how the medication works, but the recall does not specify immediate harm to users.
The tablets may not dissolve properly in the body, which could lead to incorrect medication levels. This is a manufacturing issue that affects the drug's effectiveness but does not cause immediate harm.
People with prescriptions for Prasugrel tablets who bought the specific lot numbers from Mylan. Those with the NDC code 0378-5185-93 are most at risk.
Check the NDC code 0378-5185-93 on the product label. The affected lots are 3211073, 3211074, and 3211075, expiring April 30, 2026.
Look for the NDC code 0378-5185-93 and lot numbers 3211073-3211075 on the tablet packaging.
The recall is for tablets that may not dissolve properly, which could affect medication effectiveness but does not cause immediate harm.
Check the product label for the NDC code and lot numbers. If you have the affected lots, contact Mylan for further instructions.
The recalled product has NDC 0378-5185-93 and lot numbers 3211073, 3211074, or 3211075, expiring April 30, 2026.
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-0280-2025 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0280-2025 from Mylan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
