← FDA ENFORCEMENT
D-0460-2025Class II

AvKARE

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
AvKARE
Product type
Drug
Status
Ongoing
Report date
2025-06-18
Distribution
Nationwide in the USA
Firm state
TN
Product quantity
3,817 50-count cartons
Initiated by
Voluntary: Firm initiated
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

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

Code / lot info

Lot #47881, Exp 05/31/2026

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →