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Class II: temporary or reversible health riskOngoing

Farmakeio Outsourcing Testosterone 25MG Recall

Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Ou…

FARMAKEIO OUTSOURCING LLC · Southlake, TX

Risk level
Class II
Reported by FDA
Nov 5, 2025
Recall ID
D-0123-2026
Check your lot numberHow we source this data

Summary

Farmakeio Outsourcing recalled Testosterone 25MG starting Oct 14, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0123-2026 on Nov 5, 2025. Reason: CGMP Deviations: Potential presence of metal particulate matter. Status: Ongoing.

Why it was recalled

CGMP Deviations: Potential presence of metal particulate matter

Product description

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

Lot numbers, UPCs & expiration codes

Lot 3294, EXP 4/8/2026

Where it was sold

Nationwide in the USA and Antigua

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0123-2026
Classification
Class II
Status
Ongoing
Recall initiated
Oct 14, 2025
FDA report date
Nov 5, 2025
Quantity
1,329pellets
Recall type
Voluntary: Firm initiated
Recalling firm
FARMAKEIO OUTSOURCING LLC

Original FDA data

Every field from FDA enforcement report D-0123-2026, exactly as published.

Show all FDA fields
City
Southlake
State
TX
Status
Ongoing
Country
United States
Event ID
97799
Address
920 S Kimball Ave Ste 100
Code information
Lot 3294, EXP 4/8/2026
Postal code
76092-9019
Report date
Nov 5, 2025
Product type
Drugs
Recall number
D-0123-2026
Classification
Class II
Recalling firm
FARMAKEIO OUTSOURCING LLC
Product quantity
1,329pellets
Reason for recall
CGMP Deviations: Potential presence of metal particulate matter
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide in the USA and Antigua
Recall initiation date
Oct 14, 2025
Initial firm notification
E-Mail
Center classification date
Oct 29, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0123-2026, published Nov 5, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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