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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

FarmaKeio Testosterone and Triamcinolone Pellets Recalled for Metal Particles

Agency Publication Date: October 29, 2025
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Summary

FarmaKeio Outsourcing LLC is recalling approximately 611,555 sterile testosterone and testosterone/triamcinolone acetonide pellets used for subcutaneous insertion. The recall was initiated due to manufacturing deviations that may result in the potential presence of metal particulate matter within the pellets. These prescription medications were distributed nationwide across the United States and to Antigua.

Risk

The presence of metal particles in a sterile pellet intended for insertion under the skin can cause local irritation, inflammation, or infection at the injection site. If metal matter enters the bloodstream or deeper tissues, it could pose more serious systemic health risks.

What You Should Do

  1. If you have health concerns regarding a recent pellet insertion, contact your healthcare provider or pharmacist immediately.
  2. Check the product label or your medical records for the affected brand names: Testosterone, Testosterone Regular Release, or Testosterone / Triamcinolone Acetonide Pellets.
  3. Identify if your product is included by checking the NDC codes and lot numbers on the packaging, such as NDC 73693-0389-01 (Lot 3294), NDC 73693-0387-01 (Lot 3179), or NDC 73693-0364-01 (various lots). See the Affected Products section below for the full list of affected codes.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact FarmaKeio Outsourcing LLC for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse effects.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Testosterone (25MG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3294 (Exp 4/8/2026)
NDC:
73693-0389-01

Recall #: D-0123-2026

Product: Testosterone (50MG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3179 (Exp 02/17/2026)
NDC:
73693-0387-01

Recall #: D-0124-2026

Product: Testosterone (62.5 MG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3180 (Exp 2/17/2026)
NDC:
73693-0383-01

Recall #: D-0125-2026

Product: Testosterone (87.5 MG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3193 (Exp 2/17/2026)
NDC:
73693-0386-01

Recall #: D-0126-2026

Product: Testosterone (200 MG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3203 (Exp 2/17/2026)
3284 (Exp 4/8/2026)
NDC:
73693-0381-01

Recall #: D-0127-2026

Product: Testosterone Regular Release (50 MG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3178 (Exp 02/7/2026)
NDC:
73693-0401-01

Recall #: D-0128-2026

Product: Testosterone Regular Release (200 MG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3201 (Exp 2/7/2026)
3202 (Exp 2/21/2026)
3280 (Exp 4/8/2026)
3283 (Exp 4/9/2026)
NDC:
73693-0402-01

Recall #: D-0129-2026

Product: Testosterone / Triamcinolone Acetonide (12.5MG/2.5MCG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3171 (Exp 2/11/2026)
3172 (Exp 2/11/2026)
NDC:
73693-0363-01

Recall #: D-0130-2026

Product: Testosterone / Triamcinolone Acetonide (25MG/5MCG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3148 (Exp 2/5/2026)
3154 (Exp 2/5/2026)
3155 (Exp 2/5/2026)
3162 (Exp 2/11/2026)
3167 (Exp 2/12/2026)
NDC:
73693-0379-01

Recall #: D-0131-2026

Product: Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3143 (Exp 2/5/2026)
3160 (Exp 2/11/2026)
3161 (Exp 2/11/2026)
3165 (Exp 2/12/2026)
3166 (Exp 2/12/2026)
NDC:
73693-0380-01

Recall #: D-0132-2026

Product: Testosterone / Triamcinolone Acetonide (50MG/10MCG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3091 (Exp 1/7/2026)
3096 (Exp 1/7/2026)
3097 (Exp 1/7/2026)
3182 (Exp 2/10/2026)
3186 (Exp 2/10/2026)
3187 (Exp 2/10/2026)
3188 (Exp 2/10/2026)
NDC:
73693-0365-01

Recall #: D-0133-2026

Product: Testosterone / Triamcinolone Acetonide (62.5MG/12.5MCG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3090 (Exp 1/7/2026)
3181 (Exp 2/11/2026)
3189 (Exp 2/12/2026)
3190 (Exp 2/12/2026)
NDC:
73693-0366-01

Recall #: D-0134-2026

Product: Testosterone / Triamcinolone Acetonide (87.5MG/17.5MCG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3194 (Exp 2/17/2026)
3195 (Exp 2/17/2026)
3196 (Exp 2/18/2026)
3197 (Exp 2/18/2026)
NDC:
73693-0382-01

Recall #: D-0135-2026

Product: Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
3098 (Exp 1/8/2026)
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)
NDC:
73693-0367-01

Recall #: D-0136-2026

Product: Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG)
Variants: 1 Pellet, Sterile, Subcutaneous Insertion
Lot Numbers:
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)
NDC:
73693-0364-01

Recall #: D-0137-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97799
Status: Active
Manufacturer: FARMAKEIO OUTSOURCING LLC
Sold By: Hospitals; Specialty Clinics; Healthcare Providers
Manufactured In: United States
Units Affected: 15 products (1,329pellets; 829 pellets; 829 pellets; 529 pellets; 4,929 pellets; 4,829 pellets; 14,329 pellets; 18,124 pellets; 36,924 pellets; 43,424 Pellets; 64,924 pellets; 31,124 pellets; 21,324 pellets; 103,444 pellets; 264,664 pellets)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.