HIGH

AvKARE Recalls Amantadine HCl Capsules Over Dissolution Issues

AvKARE recalled Amantadine HCl capsules on February 13, 2026, due to failed dissolution specifications. The recall affects the 100 mg capsules, which may not dissolve properly. Consumers should stop using this product and contact their healthcare provider immediately.

Quick Facts at a Glance

Recall Date
February 13, 2026
Hazard Level
HIGH
Brands
AMANTADINE HCL, AvPAK
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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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About This Product

Amantadine HCl capsules are prescription medications used to treat certain viral infections and manage symptoms of Parkinson's disease. Consumers typically buy this product for its antiviral properties and symptom relief.

Why This Is Dangerous

The recall was issued due to a failure in the dissolution specifications, meaning the capsules may not dissolve effectively and therefore may not deliver the intended dose of the medication.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may experience treatment interruptions and need to seek alternatives, prompting immediate action to ensure effective management of their health conditions.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the packaging.
  2. Verify the expiration date.
  3. Contact AvKARE for confirmation of recall status.

Where to find product info

Lot numbers and expiration dates can typically be found on the label or packaging of the product.

What timeline to expect

Expect a refund to be processed within 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Document all communication attempts with AvKARE.
  • Contact your healthcare provider for assistance.
  • File a complaint with the FDA if necessary.

How to prevent similar issues

  • Always check for recalls on prescription medications before use.
  • Stay informed about the medications you are prescribed.
  • Consult your pharmacist for alternatives if needed.

Documentation advice

Keep records of your purchase, including receipts, and document any correspondence with AvKARE regarding the recall.

Product Details

The recalled product is Amantadine HCl capsules, 100 mg, sold in units of 50 capsules. The affected lot number is 49261 with an expiration date of April 30, 2027. These capsules were distributed nationwide in the USA.

Key Facts

  • Recall date: February 13, 2026
  • Classification: Class II
  • Affected lot: 49261
  • Expiration date: April 30, 2027

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

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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