AvKARE recalls Amantadine HCl
- Recalling company
- AvKARE
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Feb 13, 2026
- Reported
- Mar 4, 2026
- Distribution
- Nationwide in the USA.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- Lot # 49261, Exp: 04/30/27
- Company location
- Pulaski, TN
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0341-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0341-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.