Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for:...
FDA Recall #D-0341-2026 — Class II — February 13, 2026
Product Description
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.
Reason for Recall
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Recalling Firm
AvKARE — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide in the USA.
Code Information
Lot # 49261, Exp: 04/30/27
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated