Warning
AvKARE Recalls Amantadine HCl
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0341-2026Drug / Pharmaceutical
AvKARE Recalls Amantadine HCl
AvKARE · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
AvKARE has recalled a pharmaceutical product that the FDA classified as Class II. The recall was initiated on February 13, 2026. Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. It was distributed nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.