Changeflow GovPing Pharma & Drug Safety Asteria Health Class II Drug Recall for Testost...
Urgent Enforcement Removed Final

Asteria Health Class II Drug Recall for Testosterone

Favicon for changeflow.com FDA: Drug Recalls Class II
Filed February 18th, 2026
Detected March 28th, 2026
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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

  1. Identify and quarantine affected Testosterone pellets
  2. Cease distribution of recalled product
  3. 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

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
February 18th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0322-2026

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Recalls Product Manufacturing
Threshold
Class II drug recall
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Product Safety Drug Manufacturing

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