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Drug FDA Class II Ongoing Failed specifications

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.

AvKARE Published Mar 4, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact AvKARE or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Failed Dissolution · primary

Affected products (1)

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.

AMANTADINE HCL · N/A

NDC: 50268-069, 50268-069-11, 50268-069-15
Lot codes: 49261
Code info: Lot # 49261, Exp: 04/30/27

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 13, 2026
  2. Published
    Mar 4, 2026
Recall number
D-0341-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.