Testosterone Pellets Recalled for Potential Metal Contamination
FarmaKeio Outsourcing is recalling testosterone pellets (lot 3178) due to potential metal contamination from manufacturing deviations. The 4,829-unit lot was distributed nationwide and internationally.
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 of an injectable product with potential metal contamination poses risk of tissue damage and infection. No illnesses or injuries have been reported, and contamination is described as potential rather than confirmed, placing this in the High severity category.
Plain-English summary
FarmaKeio Outsourcing LLC is recalling one lot of Testosterone Regular Release 50 mg pellets used for subcutaneous (under-the-skin) injection. The recall affects approximately 4,829 pellets distributed with lot number 3178 and an expiration date of February 7, 2026.
The recall was triggered by manufacturing process deviations (CGMP violations) that resulted in the potential presence of metal particulate matter in the pellets. When injected, metal particles can cause tissue damage and infection.
This lot was distributed nationwide in the United States and to Antigua. The product is prescribed by healthcare providers and dispensed through pharmacies.
Patients currently using testosterone pellets from this lot should contact their healthcare provider or pharmacy immediately to verify the lot number. Do not use pellets from lot 3178 without confirming with your provider. Ask about alternative testosterone formulations while this lot is recalled.
The recalled product
- Product
- Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01
- Manufacturer
- FARMAKEIO OUTSOURCING LLC
- Category
- Drug
- 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 (2)
- Lot: 3178
- Exp 02/7/2026
Distribution
Distributed nationwide across the United States.
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