# FDA recall D-0578-2022

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2022-02-07.

## Product

Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by:  Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-648-88.

## Reason for recall

Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup

## Distribution

Nationwide with the United States

## Key facts

- **Recall number:** D-0578-2022
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-07
- **Report date:** 2022-02-23
- **Termination date:** 2023-07-17

- **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-0578-2022

## Citation

> AI Analytics. FDA recall D-0578-2022. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-0578-2022. Source: US FDA. Licensed CC0.

---

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