Asteria Health Recalls Testosterone and Anastrozole Sterile Pellets Due to Metal Particulate Matter

Source: FDA · United States

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F.H. INVESTMENTS, Inc. (dba Asteria Health) has issued a voluntary recall for 1,464 units of 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. (dba Asteria Health) has initiated a voluntary recall of specific lots of Testosterone 100mg Anastrozole 4mg sterile pellets. The recall was prompted by the discovery of a foreign substance, identified as the potential presence of metal particulate matter within the product.

Which Products Are Affected

The recall involves 1,464 pellets of Testosterone 100mg Anastrozole 4mg (1 Sterile Pellet). The affected products carry the NDC number 79559-4104-32 and are labeled under Asteria Health, Birmingham, AL.

The following lot numbers and expiration dates are included in this recall:

  • Lot#: 254000105, Exp. 05/28/2026
  • Lot#: 254000110, Exp. 08/07/2026
  • Lot#: 254000112, Exp. 09/26/2026
  • Lot#: 254000113, Exp. 09/26/2026

What You Should Do

Consumers and healthcare providers should immediately cease use of the affected lots. The firm has initiated notification via letter. For information regarding returns or further instructions, consumers may contact F.H. INVESTMENTS, Inc. (dba Asteria Health) at 432 Industrial Ln, Birmingham, AL 35211-4465.

Why This Matters

The presence of metal particulate matter in a sterile drug product poses a significant health risk, as foreign substances can lead to adverse reactions or complications at the site of administration. This recall is classified as a Class II event by the FDA.

Source

Information provided by the FDA under Recall Number D-0331-2026.

Original source: FDA Official Notice ↗

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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 1,464 units of 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.