Amantadine HCl — Class II drug recall D-0341-2026
Ongoing recall by AvKARE, reported 2026-03-04, distributed nationwide. Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in di
| Recall number | D-0341-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AvKARE, Pulaski, TN, United States |
| Recall initiated | 2026-02-13 |
| Classified | 2026-02-23 |
| Reported by FDA | 2026-03-04 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 50268-0069, 50268-0069-11, 50268-0069-15 |
| Lot numbers | 49261 |
| Expiration dates | 2027-04-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0341-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.