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

Source: FDA · United States

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F.H. INVESTMENTS, Inc. (dba Asteria Health) has voluntarily recalled over 24,000 Estradiol 10 mg sterile pellets nationwide 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 "medium" 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), based in Birmingham, Alabama, has initiated a voluntary recall of Estradiol sterile pellets. The recall was issued due to the potential presence of a foreign substance, specifically metal particulate matter, within the product. The FDA has classified this as a Class II recall.

Which Products Are Affected

The recall affects ESTRADIOL, 10 mg, 1 Sterile Pellet, with NDC 79559-3010-32. A total of 24,099 pellets are included in this recall. The affected products were distributed nationwide in the USA and include the following lot numbers and expiration dates:

  • Lot#: 253000132, Exp. 06/16/2026
  • Lot#: 253000139 and 253000140, Exp. 07/21/2026
  • Lot#: 253000150, Exp. 08/08/2026
  • Lot#: 253000151, Exp. 08/16/2026
  • Lot#: 253000161 and 253000162, Exp. 09/12/2026

What You Should Do

Consumers and healthcare providers should immediately stop using the affected lots. The firm initiated notification to customers via letter on January 26, 2026. For questions regarding the return or replacement of these products, 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 pellet product poses a risk of injury or adverse health consequences to patients. This recall is intended to prevent potential complications associated with the administration of contaminated medication.

Source

Information provided by the FDA under Recall Number D-0308-2026.

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 voluntarily recalled over 24,000 Estradiol 10 mg sterile pellets nationwide 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 "medium" severity. Stay informed and follow agency guidance.
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.