# FDA recall D-0127-2026

> **FARMAKEIO OUTSOURCING LLC** · Class II · drug recall initiated 2025-10-14.

## Product

Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01

## Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

## Distribution

Nationwide in the USA and Antigua

## Key facts

- **Recall number:** D-0127-2026
- **Recalling firm:** FARMAKEIO OUTSOURCING LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-14
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Southlake, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0127-2026

## Citation

> AI Analytics. FDA recall D-0127-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0127-2026. Source: US FDA. Licensed CC0.

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