# FDA recall D-0574-2025

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2025-08-05.

## Product

Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01

## Reason for recall

Presence of foreign substance: identified as aluminum.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0574-2025
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-05
- **Report date:** 2025-08-13

- **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-0574-2025

## Citation

> AI Analytics. FDA recall D-0574-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0574-2025. Source: US FDA. Licensed CC0.

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