Skip to content
Back to recalls
Drug FDA Class II Ongoing Failed specifications

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.

AvKARE Published Jan 8, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact AvKARE or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications

Hazards

Failed Dissolution · primary

Affected products (1)

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.

1016 50-count cartons

Lot codes: 47101
Code info: Lot # 47101; Exp. 02/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 4, 2024
  2. Published
    Jan 8, 2025
Recall number
D-0168-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.