FDA Drug recall D-0341-2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com…
- FDA Drug
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com… by Avkare, citing failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0341-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-13 |
| Published | 2026-03-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
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
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Identifiers
| ndc | 50268-069-11 |
|---|---|
| ndc | 50268-069-15 |
| code_info | Lot # 49261, Exp: 04/30/27 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0341-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.