July 2024 FDA Recall Nitrofurantion by Sun Pharmaceutical Industries Inc
D-0597-2024 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on July 9, 2024 for the product Nitrofurantion. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0597-2024

Reason for Recall
Failed Dissolution Specifications
Initiated
07-09-2024
Reported
07-24-2024
Quantity
5752 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94950
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-22-2025
Product Description About Product Description
Full technical description of the product.
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.

Batch or Lot Expiration Information

Lot# s: 231067, 231069, Exp 04/30/2025

Affected Packages Involved in this Recall

57664-231-88 Nitrofurantion
57664-231-18 Nitrofurantion
57664-232-88 Nitrofurantion
57664-232-18 Nitrofurantion
57664-233-88 Nitrofurantion
57664-233-18 Nitrofurantion