Exact FDA event identifier

Event 97799

15 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 14, 2025
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: FARMAKEIO OUTSOURCING LLC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

15 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 15

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

D-0123-2026

Recall number: D-0123-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 1,329pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot 3294, EXP 4/8/2026

Distribution pattern

Nationwide in the USA and Antigua

drug · product 2 of 15

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

D-0124-2026

Recall number: D-0124-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 829 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot 3179, EXP 02/17/2026

Distribution pattern

Nationwide in the USA and Antigua

drug · product 3 of 15

Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01

D-0125-2026

Recall number: D-0125-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 829 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot 3180, EXP 2/17/2026

Distribution pattern

Nationwide in the USA and Antigua

drug · product 4 of 15

Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01

D-0126-2026

Recall number: D-0126-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 529 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot 3193, Exp 2/17/2026

Distribution pattern

Nationwide in the USA and Antigua

drug · product 5 of 15

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

D-0127-2026

Recall number: D-0127-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 4,929 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot, expiry: Lot 3203, exp 2/17/2026; Lot 3284, exp 4/8/2026

Distribution pattern

Nationwide in the USA and Antigua

drug · product 6 of 15

Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01

D-0128-2026

Recall number: D-0128-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 4,829 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot: 3178, Exp 02/7/2026

Distribution pattern

Nationwide in the USA and Antigua

drug · product 7 of 15

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

D-0129-2026

Recall number: D-0129-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 14,329 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot, expiry: 3201, Exp 2/7/2026; 3202, Exp 2/21/2026; 3280, Exp 4/8/2026; 3283, Exp /9/2026.

Distribution pattern

Nationwide in the USA and Antigua

drug · product 8 of 15

Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01

D-0130-2026

Recall number: D-0130-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 18,124 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot# 3171, 3172, Exp 2/11/2026

Distribution pattern

Nationwide in the USA and Antigua

drug · product 9 of 15

Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01

D-0131-2026

Recall number: D-0131-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 36,924 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot: 3148, 3154, 3155, Exp 2/5/2026; 3162, Exp 2/11/2026; 3167, Exp 2/12/2026

Distribution pattern

Nationwide in the USA and Antigua

drug · product 10 of 15

Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01

D-0132-2026

Recall number: D-0132-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 43,424 Pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot, expiry: 3143, Exp 2/5/2026; 3160, 3161, Exp 2/11/2026; 3165, 3166, Exp 2/12/2026.

Distribution pattern

Nationwide in the USA and Antigua

drug · product 11 of 15

Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01

D-0133-2026

Recall number: D-0133-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 64,924 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot: 3091, 3096, Exp 1/7/2026; 3097, Exp 1/7/2026; 3182, 3186, 3187, 3188, Exp 2/10/2026

Distribution pattern

Nationwide in the USA and Antigua

drug · product 12 of 15

Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01

D-0134-2026

Recall number: D-0134-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 31,124 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot: 3090, Exp 1/7/2026; 3181, Exp 2/11/2026; 3189, 3190, Exp 2/12/2026

Distribution pattern

Nationwide in the USA and Antigua

drug · product 13 of 15

Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01

D-0135-2026

Recall number: D-0135-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 21,324 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot, expiry: 3194, 3195, Exp 2/17/2026; 3196, 3197, Exp 2/18/2026.

Distribution pattern

Nationwide in the USA and Antigua

drug · product 14 of 15

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

D-0136-2026

Recall number: D-0136-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 103,444 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot, expiry: 3098, 3101, Exp 1/8/2026; 3107, Exp 1/13/2026; 3108, Exp 1/14/2026; 3109, Exp 1/15/2026; 3230, Exp 3/10/2026; 3231, Exp 3/11/2026; 3235, Exp 3/13/2026; 3236, Exp 3/17/2026; 3241, Exp 3/17/2026; 3242, Exp 3/18/2026.

Distribution pattern

Nationwide in the USA and Antigua

drug · product 15 of 15

Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01

D-0137-2026

Recall number: D-0137-2026
Initiated: October 14, 2025
Classification: Class II
Status: Ongoing
Recalling firm: FARMAKEIO OUTSOURCING LLC
Quantity: 264,664 pellets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Code information

Lot, expiry: 3075, Exp 1/2/2026; 3084, Exp 1/6/2026; 3110, Exp 1/15/2026; 3115, Exp 1/16/2026; 3116, Exp 1/20/2026; 3119, Exp 1/21/2026; 3121, Exp 1/22/2026; 3124, Exp 1/23/2026; 3125, Exp 1/28/2026; 3131, Exp 1/29/2026; 3134, Exp 2/3/2026; 3135, Exp 2/4/2026; 3139, Exp 2/6/2026; 3204, Exp 2/13/2026; 3205, Exp 2/18/2026; 3207, Exp 2/19/2026; 3208, Exp 2/24/2026; 3211, Exp 2/25/2026; 3213, Exp 2/26/2026; 3216, Exp 2/27/2026; 3223, Exp 3/4/2026; 3225, Exp 3/5/2026; 3228, Exp 3/6/2026; 3248, Exp 3/19/2026; 3254, Exp 3/25/2026; 3258, Exp 3/31/2026; 3269, Exp 4/1/2026; 3270, Exp 4/10/2026.

Distribution pattern

Nationwide in the USA and Antigua