Testosterone pellets recalled due to potential metal contamination from manufacturing deviations
FarmaKeio Outsourcing is recalling testosterone injection pellets (Lot 3294) due to potential metal particulate contamination from manufacturing quality control failures. No illnesses have been reported, but patients 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 of injectable testosterone involving potential metal contamination from CGMP deviations. No illnesses or injuries reported and contamination is not confirmed, making this a risk-of-harm product where injury has not yet been reported per the rubric.
Plain-English summary
FarmaKeio Outsourcing LLC is recalling Testosterone 25MG sterile pellets for subcutaneous injection (NDC 73693-0389-01, Lot 3294, expiration 4/8/2026) due to potential metal particulate contamination discovered during manufacturing quality control. A total of 1,329 pellets from this lot were distributed nationwide in the USA and Antigua.
The recall was initiated following discovery of deviations from current Good Manufacturing Practice (CGMP) standards. The potential presence of metal particles in an injectable medication could present a risk of harm if administered, though no patient illnesses or injuries have been reported.
Patients who may have received pellets from this lot should contact their healthcare provider to discuss potential risks. Healthcare providers should verify their patient records against Lot 3294 and take appropriate action if affected patients are identified.
Patients should not discontinue their testosterone therapy without medical guidance. Anyone with questions about this recall should contact their healthcare provider or pharmacy.
The recalled product
- Product
- Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
- Manufacturer
- FARMAKEIO OUTSOURCING LLC
- Category
- Drug — Injectable Hormone
- Hazard
- metal-particulate-matter
- 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 3294
- EXP 4/8/2026
Distribution
Distributed nationwide across the United States.
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