Asteria Health Recalls Testosterone and Anastrozole Sterile Pellets Due to Potential Metal Contamination

Source: FDA · United States

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F.H. INVESTMENTS, Inc. (dba Asteria Health) has issued a voluntary recall for Testosterone and Anastrozole sterile pellets due to the potential presence of metal particulate matter.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 24, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

F.H. INVESTMENTS, Inc., doing business as Asteria Health, has initiated a voluntary recall of specific sterile pellets containing Testosterone and Anastrozole. The recall was triggered by the discovery of a foreign substance, specifically the potential presence of metal particulate matter, within the product. This recall has been classified as Class II by the FDA.

Which Products Are Affected

The recall involves 100 units of the following product:

  • Product Name: Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet
  • Brand: Asteria Health
  • NDC: 79559-4104-01
  • Lot Number: 254000104
  • Expiration Date: 05/27/2026

These products were distributed nationwide across the United States.

What You Should Do

Consumers and healthcare professionals should immediately stop using the affected lot. The firm initiated the recall via letter on January 26, 2026. For further information regarding returns or specific medical concerns, consumers may contact F.H. INVESTMENTS, Inc. (dba Asteria Health) at their Birmingham, Alabama facility located at 432 Industrial Ln, Birmingham, AL 35211-4465.

Why This Matters

The presence of foreign metal particulates in a sterile pellet intended for medical use poses a serious health risk, as it can lead to local inflammation, irritation, or other complications at the site of administration.

Source

Information provided by the FDA under Recall Number D-0326-2026.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
F.H. INVESTMENTS, Inc. (dba Asteria Health) has issued a voluntary recall for Testosterone and Anastrozole sterile pellets due to the potential presence of metal particulate matter.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.