Amantadine Hcl Capsule, Liquid Filled
FDA Recall NDC 50268-069

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 2 recorded enforcement report(s) associated with Amantadine Hcl (NDC 50268-069). A significant event, classified as Class II, was initiated on Feb 13, 2026 by Avpak. The reported reason for this action was: "Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution."

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0341-2026ONGOINGD-0633-2018TERMINATED

February 2026 Class II Recall: Failed Dissolution Specifications

Recall Number
D-0341-2026
Class II Ongoing
Reason for Recall
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Initiated
Feb 13, 2026
Reported
Mar 04, 2026
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
98449
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
AvKARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
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.
Batch or Lot Expiration Information
Lot# 49261, Exp: 04/30/27
Affected Packages Involved in this Recall
50268-069-11Product
50268-069-15Product

March 2018 Class II Recall: Failed Dissolution Specifications

Recall Number
D-0633-2018
Class II Terminated
Reason for Recall
Failed Dissolution Specifications
Initiated
Mar 30, 2018
Reported
Apr 25, 2018
Quantity
2135 cartons

Recall Profile & Regulatory Data

Event ID
79680
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AVKARE Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 04, 2020
Product Description
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
Batch or Lot Expiration Information
Lot# Lot: 16719 Exp. 07/2018
Affected Packages Involved in this Recall
50268-069-11Product
50268-069-15Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.