Prasugrel Tablet, Film Coated
FDA Recall NDC 0378-5186
Latest: Class II · Status: Ongoing · Initiated Aug 17, 2026 · 3 enforcement reports
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Prasugrel (NDC 0378-5186). A significant event, classified as Class II, was initiated on Aug 17, 2026 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
August 2026 Class II Recall: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Recall Number
Class II Ongoing
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Aug 17, 2026
Sep 09, 2026
47,662 bottles
Recall Profile & Regulatory Data
Event ID
99653
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
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.
Batch or Lot Expiration Information
Lot# : 3225272, Exp. September 30, 2026
Affected Packages Involved in this Recall
0378-5185-93Prasugrel
0378-5186-93Prasugrel
February 2025 Class II Recall: Failed Dissolution Specifications - low dissolution results
Recall Number
Class II Ongoing
Failed Dissolution Specifications - low dissolution results
Feb 25, 2025
Mar 26, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96369
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
MYLAN PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
Batch or Lot Expiration Information
Lot# 3211073, 3211074, 3211075, Exp 4/30/2026
Affected Packages Involved in this Recall
0378-5185-93Prasugrel
0378-5186-93Prasugrel
Class II Terminated
Failed Dissolution Specification: Low out of specification dissolution results.
Oct 18, 2019
Nov 06, 2019
4,272 bottles
Recall Profile & Regulatory Data
Event ID
84039
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Apr 10, 2020
Product Description
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Batch or Lot Expiration Information
Lot# : 3089793, Exp. Date September 2020
Affected Packages Involved in this Recall
0378-5185-93Prasugrel
0378-5186-93Prasugrel
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
