Testosterone 200 MG Pellets Recalled for Potential Metal Contamination
FarmaKeio Outsourcing is recalling testosterone 200 mg pellets due to manufacturing deviations that could result in metal particulate matter in the product. Affected lots are 3203 and 3284.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential metal contamination from CGMP deviations—with no documented harm to date, meeting the criteria for High severity.
Plain-English summary
FarmaKeio Outsourcing LLC is recalling testosterone 200 mg pellets (1 pellet per unit) due to deviations from current good manufacturing practices (CGMP). Manufacturing irregularities could result in the potential presence of metal particulate matter in the product.
The recall affects 4,929 pellets across two lots: Lot 3203 (expiring 2/17/2026) and Lot 3284 (expiring 4/8/2026). The affected product has been distributed nationwide in the United States and to Antigua.
Patients who have received or are prescribed this testosterone pellet product should consult their healthcare provider immediately. Do not use the product. Report any adverse events to the FDA MedWatch program or the manufacturer.
The recalled product
- Product
- Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01
- Manufacturer
- FARMAKEIO OUTSOURCING LLC
- Category
- Drug — Injectable Implant
- Hazard
- metal-contamination
- cgmp-deviation
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 (5)
- Lot
- expiry: Lot 3203
- exp 2/17/2026
- Lot 3284
- exp 4/8/2026
Distribution
Distributed nationwide across the United States.
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