Reported Mar 4, 2026 · Ongoing

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN…

AvKARE

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AvKARE · 615 N 1st St · Pulaski, TN · 38478-2403

Is this the product you have?

  • Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only
  • Manufactured forAvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15
Lot codes and dates
  • Lot # 49261
  • Exp04/30/27
Amount recalled
N/A

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:03 PM UTC

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