Mylan Prasugrel Tablets Recall: Low Dissolution Risk
Mylan recalls 5mg Prasugrel tablets with low dissolution risk. Check NDC 0378-5185-93 and lots 3211073-3211075 for affected products.
Lower-risk recall
Failed Dissolution Specifications - low dissolution results
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/32265-mylan-prasugrel-tablets-recall-low-dissolution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32265-mylan-prasugrel-tablets-recall-low-dissolution-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0280-2025
Cite this page
“Mylan Prasugrel Tablets Recall: Low Dissolution Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32265-mylan-prasugrel-tablets-recall-low-dissolution-risk. Based on FDA recall #D-0280-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0280-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check the NDC code 0378-5185-93 on the product label. The affected lots are 3211073, 3211074, and 3211075, expiring April 30, 2026.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC code 0378-5185-93 and lot numbers 3211073-3211075 on the tablet packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-0280-2025 (February 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0280-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.