FDAFDA · Food and drugs·Recall number D-0341-2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
Published March 4, 2026 · Recall initiated: February 13, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMANTADINE HCL
- Manufacturer
- AvKARE
- Distributor
- Nationwide in the USA.
- Lot
- Lot # 49261, Exp: 04/30/27
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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