Testosterone/Triamcinolone injectable pellets recalled for potential metal contamination
FarmaKeio Outsourcing is recalling testosterone/triamcinolone injectable pellets due to potential metal particulate matter from manufacturing deviations. Patients should contact their healthcare provider about affected lot numbers.
What this means for you
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: This FDA Class II recall involves a risk-of-harm product (injectable medication) with a serious potential hazard (metal contamination), but no illnesses or injuries have been reported. It qualifies as High severity under the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
FarmaKeio Outsourcing LLC is recalling specific lots of Testosterone/Triamcinolone Acetonide 50MG/10MCG injectable pellets for subcutaneous insertion due to potential metal particulate matter resulting from CGMP (Current Good Manufacturing Practice) deviations.
The recalled lots are: 3091, 3096 (expiration 1/7/2026), 3097 (expiration 1/7/2026), and 3182, 3186, 3187, 3188 (expiration 2/10/2026). Approximately 64,924 pellets have been distributed nationwide in the USA and to Antigua.
Patients who have received these injectable pellets should contact their healthcare provider immediately to determine whether they received product from the affected lots. Healthcare providers should verify patient lot numbers and consider appropriate medical evaluation if exposure to contamination is suspected.
Metal particulate matter in injectable medications poses a potential risk of tissue injury or other adverse reactions at the injection site. The FDA is monitoring this recall.
The recalled product
- Product
- Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
- Manufacturer
- FARMAKEIO OUTSOURCING LLC
- Category
- Drug — Injectable Pellet
- Hazard
- metal-contamination
- manufacturing-defect
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 (9)
- Lot: 3091
- 3096
- Exp 1/7/2026
- 3097
- 3182
- 3186
- 3187
- 3188
- Exp 2/10/2026
Distribution
Distributed nationwide across the United States.
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