Testosterone/Triamcinolone Acetonide Pellets Recalled for Potential Metal Contamination
FarmaKeio Outsourcing is recalling 31,124 Testosterone/Triamcinolone Acetonide pellets due to potential metal particulate contamination from manufacturing deviations. No illnesses reported.
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 is FDA Class II with a theoretical hazard (potential metal particulate matter) and no reported illnesses or injuries. Per the rubric, Class II recalls with no reported harm and theoretical hazards score at most 3 (High).
Plain-English summary
FarmaKeio Outsourcing LLC is recalling 31,124 pellets of Testosterone/Triamcinolone Acetonide (62.5 mg/12.5 mcg) due to potential presence of metal particulate matter. The recall was initiated following identification of CGMP (Current Good Manufacturing Practice) deviations during the manufacturing process. This product is intended for subcutaneous insertion and is distributed nationwide in the USA and Antigua.
Affected product lot numbers are: 3090 (expiration 1/7/2026), 3181 (expiration 2/11/2026), 3189 (expiration 2/12/2026), and 3190 (expiration 2/12/2026). This is a prescription-only medication.
No illnesses or injuries have been reported. Healthcare providers and patients who possess affected lots should consult their physician regarding this recall.
The recalled product
- Product
- Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01
- Manufacturer
- FARMAKEIO OUTSOURCING LLC
- Category
- Drug — Injectable / Implantable
- Hazard
- metal-contamination
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 (7)
- Lot: 3090
- Exp 1/7/2026
- 3181
- Exp 2/11/2026
- 3189
- 3190
- Exp 2/12/2026
Distribution
Distributed nationwide across the United States.
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