# FDA recall D-0310-2025

> **Zydus Pharmaceuticals (USA) Inc** · Class II · drug recall initiated 2025-03-21.

## Product

Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.

## Reason for recall

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0310-2025
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-21
- **Report date:** 2025-04-16

- **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-0310-2025

## Citation

> AI Analytics. FDA recall D-0310-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0310-2025. Source: US FDA. Licensed CC0.

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