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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 49261, Exp: 04/30/27
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- AvKARE
- Reason for Recall:
- Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Lot # 49261, Exp: 04/30/27
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0341-2026
Related Recalls
Class I - Dangerous
Out of specification for dissolution.
Failed Content Uniformity Specifications
Class I - Dangerous
Presence of a foreign substance.