Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave,
Summary
The FDA issued a Class II for Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa by FARMAKEIO OUTSOURCING LLC. Reason: CGMP Deviations: Potential presence of metal particulate matter.
Details
Source
Drug Recall
External ID
D-0126-2026
Action Date
2025-11-05
Status
Ongoing
Category
drug
Product Description
Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01
Lot/Code Info: Lot 3193, Exp 2/17/2026
Quantity Affected: 529 pellets
Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Distribution
Nationwide in the USA and Antigua
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-14
Company
Southlake, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 95 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
FARMAKEIO OUTSOURCING LLC has 15 FDA actions in our database, including 15 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (FARMAKEIO OUTSOURCING LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FARMAKEIO OUTSOURCING LLC have FDA actions?
FARMAKEIO OUTSOURCING LLC has 15 FDA actions in our database, including 15 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0126-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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