Prasugrel Tablet, Film Coated
FDA Recall NDC 51407-445
Latest: Class II · Status: Ongoing · Initiated Aug 21, 2026 · 2 enforcement reports
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Prasugrel (NDC 51407-445). A significant event, classified as Class II, was initiated on Aug 21, 2026 by Golden State Medical Supply, Inc.. The reported reason for this action was: "Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution"
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. Notification from the manufacturer that lot is being recalled due to failed dissolution
Recall Number
Class II Ongoing
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Aug 21, 2026
Sep 09, 2026
6791 30-count bottles
Recall Profile & Regulatory Data
Event ID
99732
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.
Batch or Lot Expiration Information
Lot# GS062298, Exp Date: 09/30/ 2026.
Affected Packages Involved in this Recall
51407-444-30Prasugrel
51407-445-30Prasugrel
Class II Ongoing
Failed Dissolution Specifications
Mar 05, 2025
Mar 26, 2025
2,601 30-count bottles
Recall Profile & Regulatory Data
Event ID
96441
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
Batch or Lot Expiration Information
Lot# Lot no's: GS059908, GS060228, GS060709, GS061233, GS061704, GS062158, GS062405, Exp.: 04/30/2026
Affected Packages Involved in this Recall
51407-444-30Prasugrel
51407-445-30Prasugrel
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.
