# FDA recall D-0460-2025

> **AvKARE** · Class II · drug recall initiated 2025-05-13.

## Product

Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478.  NDC 50268-169-15

## Reason for recall

Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0460-2025
- **Recalling firm:** AvKARE
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-13
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0460-2025

## Citation

> AI Analytics. FDA recall D-0460-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0460-2025. Source: US FDA. Licensed CC0.

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