HIGH

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.

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

Quick Facts at a Glance

Recall Date
February 13, 2026
Hazard Level
HIGH
Brands
AMANTADINE HCL, AvPAK
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact AvKARE or your healthcare provider for guidance. Notification method: Letter

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Full 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.. Generic: AMANTADINE HYDROCHLORIDE; Brand: AMANTADINE HCL. Reason: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.. Classification: Class II. Quantity: N/A. Distribution: Nationwide in the USA.

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Product Classification

Product Details

Model Numbers
Lot # 49261
Exp: 04/30/27
UPC Codes
50268-069
50268-069-11
50268-069-15
Affected States
ALL
Report Date
March 4, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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