Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES Recalled by Alvogen, Inc Due to Failed Dissolution Specification; 6 month time point

Date: April 21, 2015
Company: Alvogen, Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alvogen, Inc directly.

Affected Products

NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01

Quantity: 13,392 bottles (100 count)

Why Was This Recalled?

Failed Dissolution Specification; 6 month time point

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Alvogen, Inc

Alvogen, Inc has 21 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report