Is this recall still active?

The FDA lists the recall as ongoing. The recall is still in progress.

Checked Oct 26, 2026

Class IIDrug recallOngoing

Testosterone / Triamcinolone Acetonide recall

Recalled by FARMAKEIO OUTSOURCING LLC of Southlake, TX · FDA report 11/05/2025

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class II; Moderate
Status: Ongoing
Recall started: 10/14/2025
Distribution: Nationwide

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

Product: Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01
Lot and code info: Lot# 3171, 3172, Exp 2/11/2026
Quantity: 18,124 pellets
Recall number: D-0130-2026
Event ID: 97799
Initiated by: Voluntary: Firm initiated

Where it was distributed

Nationwide in the USA and Antigua

Nationwide

Recall timeline

10/14/2025Firm started the recall
10/29/2025FDA classified it as Class II
11/05/2025Published in the FDA enforcement report

All products in this recall

15 products under event 97799

Frequently asked questions

Why was Testosterone / Triamcinolone Acetonide recalled?: CGMP Deviations: Potential presence of metal particulate matter
What does Class II mean?: Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?: Nationwide in the USA and Antigua
Is this recall still active?: The FDA lists the recall as ongoing. The recall is still in progress.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 11/05/2025 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class II
Status: Ongoing
Type: Drug
Reported: 11/05/2025

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

Browse recalls

About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

DatenUS is a private website and is not affiliated with or endorsed by any government agency. We republish public data from the sources listed on this page. Data can be incomplete, delayed or wrong. Always check the original source before you make a decision.

Our servers read this data automatically from government sources. Errors can come from the source itself or from the way we read, process or display it, and we do not guarantee that it is accurate, complete or current. Verify anything important with the official source.

Report an error Read the full disclaimer