Recall: D-0341-2026

Class II - Potentially Harmful

Class IIClassification

2026-02-13Initiated

OngoingStatus

AvKAREFirm

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.

Reason

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

Distribution

Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.