D-0597-2024 Class II Terminated
FDA drug recall D-0597-2024 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Jul 9, 2024 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated Dec 22, 2025). Affected quantity: 5752 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 24, 2024
- Initiation Date
- Jul 9, 2024
- Termination Date
- Dec 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5752 bottles
Product Description
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.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide in the USA and Puerto rico
Code Information
Lot #s: 231067, 231069, Exp 04/30/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0597-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026