FDA-Drug2026-02-18Class IIPROCESSING DEFECT

Asteria Health testosterone pellets recalled for potential metal particulate contamination

METALNationwide distributionDrugs

What this means

Asteria Health testosterone pellets (25 mg) may contain metal particulate matter due to a manufacturing issue. The FDA has classified this as a Class II recall affecting multiple lot numbers distributed nationwide. No injuries have been reported to date.

  • Check if you have an affected lot number (251000130, 251000137, 251000152, 251000168, or 251000170)
  • Do not use pellets from affected lots
  • Contact your healthcare provider or pharmacy for guidance on replacement or alternative treatment
  • Return unused pellets to your pharmacy
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The agency's original wording
Hazard

Presence of Foreign substance - potential presence of metal particulate matter

Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
89,074 pellets
Manufactured in
432 Industrial Ln, N/A, Birmingham, AL, United States
Products
Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0318-2026

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