Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: A...

FDA Recall #D-0460-2025 — Class II — May 13, 2025

Recall #D-0460-2025 Date: May 13, 2025 Classification: Class II Status: Ongoing

Product Description

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

Recalling Firm

AvKARE — Pulaski, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3,817 50-count cartons

Distribution

Nationwide in the USA

Code Information

Lot #47881, Exp 05/31/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated