Mylan recalls 5mg Prasugrel tablets with low dissolution results. This may affect drug effectiveness. Check NDC 0378-5185-93 and lot 3089793 for affected products.
“Mylan Prasugrel Tablets 5mg: Failed Dissolution Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37821-mylan-prasugrel-tablets-5mg-failed-dissolution-risk. Based on FDA recall #D-0155-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0155-2020%22&limit=1).
The FDA announced on Oct. 18, 2019, that Mylan Pharmaceuticals Inc. voluntarily recalled Prasugrel Tablets 5 mg due to failed dissolution specifications. The agency issued recall number D-0155-2020 for the drug classed as Class II.
How to tell if you have it
Brand: Mylan
Product: Prasugrel Tablets 5 mg, 30-count bottles
NDC: 0378-5185-93
Lot #: 3089793
Exp. Date: September 2020
Quantity: 4,272 bottles
The hazard
The recall addresses low out-of-specification dissolution results for the Prasugrel Tablets. The FDA classified this issue as a Class II recall.
Context
GovInfoNow's records show Mylan Pharmaceuticals Inc. has had 54 other recalls since June 28, 2012. Recent similar recalls include Mylan Mycophenolate Mofetil Injections (Aug. 26, 2026), Mylan Prasugrel Tablets (Aug. 17, 2026), and Mylan Acamprosate Tablets (July 24, 2026). Other recent recalls of similar products include Golden State Medical Recalls Prasugrel HCl 10mg Tablets (Aug. 21, 2026) and Viatris Xanax XR 3mg Tablets Recall (March 17, 2026).
How to tell if you have this one
Check for the NDC code 0378-5185-93 and lot number 3089793 on the product label. These tablets were sold in the U.S. with an expiration date of September 2020.
Brand
Mylan
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the NDC code 0378-5185-93 and lot number 3089793 on the tablet packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0155-2020 (October 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0155-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.