AvKARE recalls Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 3…

Recall date

February 13, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0341-2026

FDA classification

Class II

Brand / firm

AvKARE

Sold / distributed

Nationwide in the USA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.