Drug FDA Class II Ongoing Foreign material

Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01

FARMAKEIO OUTSOURCING LLC Published Nov 5, 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 FARMAKEIO OUTSOURCING LLC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Hazards

Metal Particulate Matter · primary

Affected products (1)

Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01

829 pellets

Lot codes: 3180

Code info: Lot 3180, EXP 2/17/2026

Affected areas

Nationwide

Timeline

Initiated

Oct 14, 2025
Published

Nov 5, 2025

Recall number: D-0125-2026
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.