Amantadine Hcl, Capsules, Ups, 100 Mg, 50 Capsules (5 X 10) Unit Dose, Rx Only, Manufactured For: Avkare, Pulaski, Tn 38478, Www.avkare.com
AvKARE is recalling Amantadine HCl 100 mg capsules (NDC 50268-069-15) nationwide because the capsules failed to meet dissolution specifications, meaning they may not break down properly in the body. This is a Class I recall, the most serious type. The affected product was distributed across all U.S. states and the District of Columbia.
- Recalling firm
- 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 I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-02-13
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/4a630c64-e84b-44ee-8208-7e76b2073bd3