# FDA recall D-0247-2026

> **Zydus Pharmaceuticals (USA) Inc** · Class III · drug recall initiated 2025-12-19.

## Product

traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10

## Reason for recall

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0247-2026
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-12-19
- **Report date:** 2026-01-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0247-2026

## Citation

> AI Analytics. FDA recall D-0247-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0247-2026. Source: US FDA. Licensed CC0.

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