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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- AMANTADINE HCL, AvPAK
- Product type
- Amantadine HCl Capsules
- Model numbers
- Lot # 49261, Exp: 04/30/27
- UPC codes
- 50268-069, 50268-069-11, 50268-069-15
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 13, 2026
Reported by FDA DRUG
March 4, 2026
RecallRadar source check
March 11, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the lot number on the packaging.
- Verify the expiration date.
- 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.
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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
- Expiration date: April 30, 2027
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Safety Guide
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