Asteria Health Class II Drug Recall for Testosterone
Summary
The FDA has initiated a Class II drug recall for Asteria Health's Testosterone pellets due to the potential presence of metal particulate matter. The recall affects product distributed nationwide in the USA.
What changed
The Food and Drug Administration (FDA) has issued a Class II drug recall for Asteria Health's Testosterone, 87.5 mg, 1 Sterile Pellet (NDC: 79559-1087-32). The reason for the recall is the potential presence of metal particulate matter, which poses a risk to patient safety. The product was distributed nationwide across the USA.
This recall signifies a significant product safety issue for Asteria Health and potentially other entities involved in the distribution chain. Companies handling this product must immediately identify and quarantine affected inventory, cease distribution, and comply with FDA recall procedures. Failure to comply with recall directives can result in further enforcement actions and penalties.
What to do next
- Identify and quarantine affected Testosterone pellets
- Cease distribution of recalled product
- Comply with FDA recall procedures
Source document (simplified)
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0322-2026 · 20260218 · Ongoing
Product
Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
Reason for Recall
Presence of Foreign substance - potential presence of metal particulate matter
Distribution
Nationwide in the USA
Source: openFDA Enforcement API
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