Testosterone Implant Pellets Recalled for Potential Metal Contamination
FarmaKeio Outsourcing is recalling 14,329 testosterone pellets due to potential metal particulate matter from manufacturing deviations. Affected lots distributed nationwide are being recalled as a precaution.
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 an FDA Class II recall for a risk-of-harm product (metal contamination in injectable medication). No illnesses or injuries have been reported, and the hazard is stated as potential rather than confirmed. Per the rubric, recalls of risk-of-harm products without reported injury score as High.
Plain-English summary
FarmaKeio Outsourcing LLC is recalling Testosterone Regular Release 200 MG implant pellets (NDC 73693-0402-01) due to CGMP deviations that resulted in the potential presence of metal particulate matter. The recall affects 14,329 pellets distributed nationwide in the USA and Antigua.
The affected lots include: Lot 3201 (Exp 2/7/2026), Lot 3202 (Exp 2/21/2026), Lot 3280 (Exp 4/8/2026), and Lot 3283 (Exp /9/2026). These sterile implants are intended for subcutaneous insertion by healthcare providers.
Patients who received these implants should contact their healthcare provider immediately to discuss whether their pellet was from an affected lot. Consumers should not attempt to remove implants themselves and should seek medical guidance. Healthcare providers should identify patients who received affected lots and determine appropriate medical follow-up.
No illnesses or injuries have been reported to date. The recall is being issued as a precaution due to the manufacturing deviation and potential product defect.
The recalled product
- Product
- Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
- Manufacturer
- FARMAKEIO OUTSOURCING LLC
- Category
- Drug — Testosterone implants
- 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 (9)
- Lot
- expiry: 3201
- Exp 2/7/2026
- 3202
- Exp 2/21/2026
- 3280
- Exp 4/8/2026
- 3283
- Exp /9/2026.
Distribution
Distributed nationwide across the United States.
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