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.
What this means for you
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.
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