FDAHealthFebruary 13, 2026
AvKARE — 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.
⚠️ Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 13, 2026
Nationwide in the USA.
What's affected?
- Product
- 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.
- Brand
- AMANTADINE HCL
- Lot code
- 49261
Additional details
Lot # 49261, Exp: 04/30/27
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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