# FDA recall D-0566-2025

> **Alembic Pharmaceuticals Limited** · Class II · drug recall initiated 2025-07-25.

## Product

Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31

## Reason for recall

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0566-2025
- **Recalling firm:** Alembic Pharmaceuticals Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-25
- **Report date:** 2025-08-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0566-2025

## Citation

> AI Analytics. FDA recall D-0566-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0566-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*