Shire Recalls Vyvanse Capsules Due to Presence of Foreign Tablets
Shire is recalling 7,680 bottles of Vyvanse 30 mg capsules because foreign tablets or capsules were found in the product.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because adverse health consequences are unlikely.
Plain-English summary
Shire is voluntarily recalling 7,680 bottles (768,000 capsules) of Vyvanse (lisdexamfetamine dimesylate) 30 mg capsules. The recall is being conducted because foreign tablets or capsules were found in the product.
The affected product is identified by Lot # AF3360B with an expiration date of 04/19. The product was distributed nationwide. The specific NDC for the recalled 100-count bottles is 59417-103-10.
Consumers who have this product should stop using it and contact their pharmacist or Shire for a replacement or refund. The FDA classifies this recall as Class III, indicating that there is a remote probability that adverse health consequences will be.
The recalled product
- Product
- VYVANSE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- VYVANSE
- Manufacturer
- Shire
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # AF3360B
- Exp. 04/19
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Shire
See all →- SevereShire Recalls Kalbitor Due to Presence of Glass Particulate Matter
FDA (Drugs) · 2017-04-12
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateShire Recalls Pentasa Capsules Due to Presence of Foreign 500 mg Tablets
FDA (Drugs) · 2017-01-25
- SevereMylan Recalls Levetiracetam Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2012-10-03
- SevereMerck Recalls Vytorin Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2015-10-14
- HighTrazodone tablets recalled over the presence of foreign tablets
FDA (Drugs) · 2026-02-11
- ModerateActavis Recalls Nifedipine Capsules Due to Presence of Foreign Tablets
FDA (Drugs) · 2016-11-30
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23