FDA recall D-0341-2026

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 for recall

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

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2026-02-13

Report date

2026-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0341-2026