Amantadine HCl recall (AvKARE)
DrugClass IIOngoing
Summary: AvKARE is recalling 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: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
What is being recalled
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.
Why
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA.
How to tell if yours is affected
Lot # 49261, Exp: 04/30/27
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0341-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 13, 2026 |
| Reported | March 4, 2026 |
| Company | AvKARE |
| Company location | Pulaski, TN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
More recalls from AvKARE · all drug recalls · recalls from February 2026