Multi-event October 2025 FDA Recall Drug by Farmakeio Outsourcing Llc

This Multi-event Class II drug recall was voluntarily initiated by Farmakeio Outsourcing Llc on October 14, 2025 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.

Reported Recall Events

Recall Number: D-0133-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
64,924 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

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

Recall Number: D-0124-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
829 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

Lot# Lot 3179, EXP 02/17/2026

Recall Number: D-0125-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
829 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

Lot# Lot 3180, EXP 2/17/2026

Recall Number: D-0123-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
1,329pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

Lot# Lot 3294, EXP 4/8/2026

Recall Number: D-0130-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
18,124 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

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

Recall Number: D-0135-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
21,324 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

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

Recall Number: D-0129-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
14,329 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

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

Recall Number: D-0136-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
103,444 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

Lot# 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.

Recall Number: D-0131-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
36,924 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

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

Recall Number: D-0132-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
43,424 Pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

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

Recall Number: D-0137-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
264,664 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

Lot# 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.

Recall Number: D-0134-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
31,124 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

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

Recall Number: D-0126-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
529 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

Lot# Lot 3193, Exp 2/17/2026

Recall Number: D-0128-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
4,829 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

Lot# Lot: 3178, Exp 02/7/2026

Recall Number: D-0127-2026

Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Initiated
10-14-2025
Reported
11-05-2025
Quantity
4,929 pellets

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
FARMAKEIO OUTSOURCING LLC
Nationwide in the USA and Antigua
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

Batch or Lot Expiration Information

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