FDA Recalls Testosterone/Triamcinolone Acetonide Pellets Due to Potential Metal Contamination

Plain-English summary

FarmaKeio Outsourcing LLC is recalling Testosterone/Triamcinolone Acetonide Pellets (100 mg/20 mcg). The recall affects 103,444 pellets distributed nationwide in the USA and Antigua under NDC 73693-0367-01. Affected lots include 3098, 3101, 3107, 3108, 3109, 3230, 3231, 3235, 3236, 3241, and 3242, with expiration dates ranging from January 8, 2026, to March 18, 2026.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that identified a potential presence of metal particulate matter in the pellets. These metal particles could present a safety risk, particularly given that the pellets are designed for subcutaneous insertion.

The product was distributed nationwide in the United States and Antigua. Patients who may have received one of the affected pellets should contact their healthcare provider or FarmaKeio Outsourcing LLC for information regarding their specific lot number.

The recalled product

Product

Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01

Manufacturer

FARMAKEIO OUTSOURCING LLC

Category

Drug — Compounded Hormone Pellet

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.

Distribution

Distributed nationwide across the United States.

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