AvKARE Issues Voluntary Recall for Amantadine HCl Capsules Due to Dissolution Failure

Source: FDA · United States

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AvKARE has initiated a voluntary recall of Amantadine HCl Capsules, 100 mg, after the product failed to meet dissolution specifications during testing.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on March 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

AvKARE has initiated a voluntary recall of Amantadine HCl Capsules, USP, 100 mg. The recall was triggered by an "Out of Specification" finding during dissolution testing. This failure to meet dissolution specifications means the medication may not break down as intended once ingested.

Which Products Are Affected

The recall affects the following specific product lot distributed nationwide across the United States:

  • Product Name: Amantadine HCl, Capsules, USP, 100 mg
  • Configuration: 50 Capsules (5 x 10) unit dose
  • NDC Number: 50268-069-15 (associated with package NDCs 50268-069-11 and 50268-069-15)
  • Lot Number: 49261
  • Expiration Date: 04/30/27
  • Recall Number: D-0341-2026

The product was manufactured for AvKARE, based in Pulaski, Tennessee.

What You Should Do

Consumers, pharmacists, and healthcare providers should immediately check their inventory for Lot # 49261. If you have the affected product, you should stop using or distributing it. For information regarding returns or further instructions, contact AvKARE at their Pulaski, TN office or visit their official website at www.avkare.com. The firm originally notified affected parties via letter starting on February 13, 2026.

Why This Matters

Dissolution specifications are critical for ensuring that a drug is absorbed by the body at the correct rate and concentration. A failure in dissolution can impact the therapeutic effectiveness of the prescription medication.

Source

Information provided by the U.S. Food and Drug Administration (FDA).

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
AvKARE has initiated a voluntary recall of Amantadine HCl Capsules, 100 mg, after the product failed to meet dissolution specifications during testing.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.