# FDA recall D-0597-2024

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2024-07-09.

## 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.

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide in the USA and Puerto rico

## Key facts

- **Recall number:** D-0597-2024
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-07-09
- **Report date:** 2024-07-24
- **Termination date:** 2025-12-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0597-2024

## Citation

> AI Analytics. FDA recall D-0597-2024. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0597-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*