FDA Recall D-0341-2026
AvKARE · Pulaski, TN
Class II Ongoing 90 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Recall record
- Recall number
D-0341-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA.
- Recall initiated
- 2026-02-13
- Classified by FDA Center
- 2026-02-23
- FDA published
- 2026-03-04
- Recalling firm
- AvKARE
- Firm location
- Pulaski, TN
Drug identification
- Brand name(s)
- AMANTADINE HCL
- Generic name(s)
- AMANTADINE HYDROCHLORIDE
- Manufacturer(s)
- AvPAK
- NDC(s)
50268-069- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.