# FDA recall D-0516-2026

> **Ajanta Pharma Ltd.** · Class II · drug recall initiated 2026-04-29.

## Product

Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.

## Reason for recall

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

## Distribution

Nationwide within U.S

## Key facts

- **Recall number:** D-0516-2026
- **Recalling firm:** Ajanta Pharma Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-29
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aurangabad, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0516-2026

## Citation

> AI Analytics. FDA recall D-0516-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0516-2026. Source: US FDA. Licensed CC0.

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