# FDA recall D-0459-2025

> **Alembic Pharmaceuticals Limited** · Class II · drug recall initiated 2025-05-09.

## Product

Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71

## Reason for recall

Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

## Distribution

Distributed Nationwide and in PR

## Key facts

- **Recall number:** D-0459-2025
- **Recalling firm:** Alembic Pharmaceuticals Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-09
- **Report date:** 2025-06-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0459-2025

## Citation

> AI Analytics. FDA recall D-0459-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0459-2025. Source: US FDA. Licensed CC0.

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