Vyvanse Capsule
FDA Recall NDC 59417-101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Vyvanse (NDC 59417-101). A significant event, classified as Class III, was initiated on Sep 02, 2016 by Takeda Pharmaceuticals America, Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Presence of Foreign Tablets/Capsules
Sep 02, 2016
Oct 12, 2016
7,680 bottles (768,000 capsules)
Recall Profile & Regulatory Data
Event ID
75170
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Shire
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 08, 2019
Product Description
Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10
Batch or Lot Expiration Information
Lot# AF3360B; Exp. 04/19
Affected Packages Involved in this Recall
59417-101-10Product
59417-102-10Product
59417-103-10Product
59417-104-10Product
59417-105-10Product
59417-106-10Product
59417-107-10Product
59417-115-01Product
59417-116-01Product
59417-117-01Product
59417-118-01Product
59417-119-01Product
59417-120-01Product
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.
