Amantadine HCl Capsules — Class II drug recall D-0633-2018
Terminated recall by AVKARE Inc., reported 2018-04-25, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0633-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2018-03-30 |
| Classified | 2018-04-17 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2020-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 2,135 cartons |
| Reason classes | specification failure |
| NDC | 50268-0069, 50268-0069-11, 50268-0069-15 |
| Lot numbers | 16719 |
| Expiration dates | 2018-07 |
Product
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
Reason for recall
Failed Dissolution Specifications
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-0633-2018. 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.