# FDA recall D-0400-2026

> **Zydus Pharmaceuticals (USA) Inc** · Class II · drug recall initiated 2026-03-09.

## Product

Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.  NDC: 70710-1592-7

## Reason for recall

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0400-2026
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-09
- **Report date:** 2026-03-18

- **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-0400-2026

## Citation

> AI Analytics. FDA recall D-0400-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0400-2026. Source: US FDA. Licensed CC0.

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