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.

Recall Number: D-0341-2026

Firm: AvKARE

Classification: Class II

Status: Ongoing

Report Date: 20260304

Initiation Date: 20260213

Termination Date:

Reason for Recall

Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.

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.