Recall
FDAHealthFebruary 13, 2026

AvKARE — 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
February 13, 2026

Nationwide in the USA.

What's affected?

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.
Lot code
49261

Additional details

Lot # 49261, Exp: 04/30/27

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: N/A.

View original FDA notice →

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