Asteria Health Recalls Testosterone Sterile Pellets Due to Potential Metal Particulate Matter

Source: FDA · United States

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F.H. INVESTMENTS, Inc. (dba Asteria Health) is recalling 153,498 testosterone pellets nationwide due to the potential presence of metal particulate matter in the sterile product.

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 several lots of its Testosterone sterile pellets. The recall was prompted by the discovery of a foreign substance, specifically the potential presence of metal particulate matter, within the product. The FDA has classified this as a Class II recall.

Which Products Are Affected

The recall affects 153,498 units of the following product distributed nationwide across the United States:

  • Product Name: Testosterone, 100 mg, 1 Sterile Pellet
  • NDC Number: 79559-1100-32
  • Manufacturer: Asteria Health, 432 Industrial Ln, Birmingham, AL 35211
  • Affected Lot Numbers and Expiration Dates:
    • Lot 251000132 (Exp. 06/16/2026)
    • Lot 251000142 (Exp. 06/30/2026)
    • Lot 251000144 (Exp. 07/14/2026)
    • Lot 251000146 (Exp. 07/21/2026)
    • Lot 251000162 (Exp. 08/16/2026)
    • Lot 251000163 (Exp. 08/16/2026)
    • Lot 251000167 (Exp. 08/22/2026)
    • Lot 251000177 (Exp. 09/12/2026)

What You Should Do

Healthcare providers and consumers who have the affected lots should immediately stop using the product. Asteria Health notified its customers of the recall via letter starting on January 26, 2026. For further information regarding returns or specific instructions, parties should contact F.H. INVESTMENTS, Inc. at their Birmingham, Alabama location.

Why This Matters

The presence of metal particulate matter in a sterile drug product intended for implantation poses a serious health risk, as it can lead to inflammation, irritation, or other adverse tissue reactions at the site of administration.

Source

This information is based on official recall data from the FDA under recall number D-0323-2026.

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) is recalling 153,498 testosterone pellets nationwide due to the potential presence of metal particulate matter in the sterile product.
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.