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.

FDA recall notice · announced March 4, 2026 · Avkare

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot # 49261, Exp: 04/30/27
Quantity: N/A
Status: Ongoing
Products in this recall event:
- 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. (D-0341-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.