Testosterone pellets recalled due to potential metal particulate contamination
FarmaKeio Outsourcing is recalling Testosterone 50mg pellets (Lot 3179) nationwide due to potential metal particulate matter from manufacturing defects. Patients currently using this product should contact their healthcare provider.
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 for potential metal contamination in an injectable product with no reported illnesses or injuries. This meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' supporting a High severity score.
Plain-English summary
FarmaKeio Outsourcing LLC is recalling Testosterone 50mg sterile pellets for subcutaneous insertion distributed nationwide in the USA and Antigua. The recall affects Lot 3179 with an expiration date of February 17, 2026, involving approximately 829 pellets.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered during manufacturing. The company identified a potential presence of metal particulate matter in the affected product.
This is an FDA Class II recall. Patients currently using this product should contact their healthcare provider or pharmacy immediately to discuss appropriate next steps. The product should not be used until guidance from a healthcare provider is received.
The recalled product
- Product
- Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01
- Manufacturer
- FARMAKEIO OUTSOURCING LLC
- Category
- Drug
- Hazard
- metal-particulate
- 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 3179
- EXP 02/17/2026
Distribution
Distributed nationwide across the United States.
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