AvKARE recalls Amantadine HCl capsules 100 mg over failed dissolution test
The capsules had an out-of-specification result in a dissolution test, which means they failed the dissolution specifications set for the product.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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.
- Company
- AvKARE
- Hazard
- Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
- Units
- N/A
- Where sold
- Nationwide in the USA.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- February 23, 2026
- Recall started
- February 13, 2026
- FDA enforcement report
- March 4, 2026
- Identifiers
- Codes: Lot # 49261, Exp: 04/30/27
- FDA recall number: D-0341-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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.
- Reason for recall
- Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
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