OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Mylan Pharmaceuticals Inc recalls Prasugrel Tablets

Recall date · record updated Sep 9, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Mylan Pharmaceuticals Inc
Reason
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Nationwide within the U.S
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99653…

Products

  1. Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.

    Codes/lots: Lot #: 3225272, Exp. September 30, 2026Quantity: 47,662 bottlesRecall no. D-0839-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

More Medicines & devices recalls