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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

AvKARE Amantadine HCl Capsules Recalled for Failed Dissolution

Agency Publication Date: February 23, 2026
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Summary

AvKARE is voluntarily recalling one lot of Amantadine HCl (100 mg) capsules, a medication used to treat Parkinson's disease and certain viral infections. The recall was issued because the drug failed dissolution testing, which means the capsules may not dissolve properly in the body as intended. Consumers who have this medication should check their packaging for the specific lot number and expiration date listed below. If you are taking this medication, contact your healthcare provider or pharmacist to discuss your treatment and how to obtain a replacement.

Risk

If the medication does not dissolve correctly, the body may not absorb the necessary amount of the active ingredient, potentially making the treatment less effective for managing symptoms or infections.

What You Should Do

  1. Identify if your product is affected by checking the packaging for Amantadine HCl Capsules, 100 mg (50-count unit dose) with Lot # 49261 and an expiration date of 04/30/27.
  2. If you have health concerns related to this medication, contact your healthcare provider or pharmacist immediately.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact AvKARE for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Amantadine HCl Capsules (50 Capsules unit dose)
Variants: 100 mg
Lot Numbers:
49261 (Exp: 04/30/27)
NDC:
50268-069-15

Recall #: D-0341-2026; UPS specifications

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98449
Status: Active
Manufacturer: AvKARE
Sold By: Pharmacies
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.