FDA DrugsClass II
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, ...
Published: March 4, 2026Recall ID: D-0341-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Pulaski |
| State | TN |
| Openfda › Unii | M6Q1EO9TD0 |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 849389 |
| Openfda › Spl id | 38566e1f-b7b1-540f-e063-6394a90a2760 |
| Openfda › Brand name | AMANTADINE HCL |
| Openfda › Spl set id | 461e6444-189e-62ed-6c61-1c36a04459c6 |
| Openfda › Package ndc › 1 | 50268-069-11 |
| Openfda › Package ndc › 2 | 50268-069-15 |
| Openfda › Product ndc | 50268-069 |
| Openfda › Generic name | AMANTADINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | AMANTADINE HYDROCHLORIDE |
| Openfda › Manufacturer name | AvPAK |
| Openfda › Application number | ANDA078720 |
| Openfda › Original packager product ndc | 69452-142 |
| Event id | 98449 |
| Address 1 | 615 N 1st St |
| Address 2 | N/A |
| Code info | Lot # 49261, Exp: 04/30/27 |
| Postal code | 38478-2403 |
| Report date | 20260304 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260213 |
| Initial firm notification | Letter |
| Center classification date | 20260223 |
Overview
- Recalling FirmAvKARE
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA.