# FDA recall D-0100-2025

> **Amerisource Health Services LLC** · Class II · drug recall initiated 2024-11-14.

## Product

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories

## Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

## Distribution

PA, OH, PR

## Key facts

- **Recall number:** D-0100-2025
- **Recalling firm:** Amerisource Health Services LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-11-14
- **Report date:** 2024-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0100-2025

## Citation

> AI Analytics. FDA recall D-0100-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0100-2025. Source: US FDA. Licensed CC0.

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