# FDA recall D-0273-2024

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2024-01-18.

## Product

Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.

## Reason for recall

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0273-2024
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2024-01-18
- **Report date:** 2024-01-31

- **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-0273-2024

## Citation

> AI Analytics. FDA recall D-0273-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0273-2024. Source: US FDA. Licensed CC0.

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