# FDA recall D-0248-2026

> **Alembic Pharmaceuticals Limited** · Class III · drug recall initiated 2025-12-16.

## Product

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30

## Reason for recall

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

## Distribution

US Nationwide and PR.

## Key facts

- **Recall number:** D-0248-2026
- **Recalling firm:** Alembic Pharmaceuticals Limited
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-12-16
- **Report date:** 2026-01-14

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0248-2026

## Citation

> AI Analytics. FDA recall D-0248-2026. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0248-2026. Source: US FDA. Licensed CC0.

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