Drug FDA Class II Ongoing Foreign material

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

AvKARE Published Jun 18, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact AvKARE or your place of purchase with questions, and see the source record below for full details.

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

Hazards

Tadalafil 5mg Tablet · primary

Affected products (1)

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

CELECOXIB · 3,817 50-count cartons

NDC: 50268-168, 50268-169, 50268-168-11, 50268-168-15, 50268-169-11, 50268-169-15

Lot codes: 47881

Code info: Lot #47881, Exp 05/31/2026

Affected areas

Nationwide

Timeline

Initiated

May 13, 2025
Published

Jun 18, 2025

Recall number: D-0460-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.