AvKARE recalls Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc…

Recall date

December 4, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0168-2025

FDA classification

Class II

Brand / firm

AvKARE

Sold / distributed

Nationwide USA

Why it was recalled

Failed Dissolution Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.