Testosterone pellets recalled over potential presence of metal particulate matter
FarmaKeio Outsourcing is recalling 1,329 sterile Testosterone 25 mg pellets from one lot over the potential presence of metal particulate matter.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: metal particulate in a product inserted under the skin is a hazard, and no injuries are reported.
Plain-English summary
Testosterone 25 mg, one sterile pellet for subcutaneous insertion, compounded by FarmaKeio Outsourcing of Southlake, Texas, is being recalled for CGMP deviations: the potential presence of metal particulate matter.
The recall covers 1,329 pellets from lot 3294, expiring 8 April 2026, carrying NDC 73693-0389-01. The product was distributed nationwide in the United States and in Antigua. The FDA has classified the recall as Class II.
The pellet is inserted under the skin, so foreign particulate matter would be introduced into the body. The enforcement record describes the potential contamination and reports no injuries.
Providers and patients holding lot 3294 should stop using it and contact the firm or their prescriber.
The recalled product
- Product
- Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
- Manufacturer
- FARMAKEIO OUTSOURCING LLC
- Category
- Drug — Hormone implant
- Affected units
- 1,329
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 3294
- EXP 4/8/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by FARMAKEIO OUTSOURCING LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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