Asteria Health Recalls Estradiol Sterile Pellets Due to Potential Metal Contamination

Source: FDA · United States

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F.H. INVESTMENTS, Inc. (dba Asteria Health) has voluntarily recalled 1,699 Estradiol sterile pellets after discovering 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 its Estradiol sterile pellets. The recall was triggered by 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 was initiated by the firm via letter notification on January 26, 2026.

Which Products Are Affected

The recall involves 1,699 units of the following product distributed nationwide in the United States:

  • Product Name: ESTRADIOL, 18 mg, 1 Sterile Pellet
  • NDC: 79559-3018-32
  • Lot Number: 253000123
  • Expiration Date: 06/02/2026
  • Manufacturer: Asteria Health, 432 Industrial Ln, Birmingham, AL 35211

What You Should Do

Healthcare providers and consumers who have the affected lot of Estradiol pellets should immediately cease use of the product. Asteria Health notified customers of the recall through a formal letter. For information regarding the return process or to report adverse events, consumers should contact F.H. INVESTMENTS, Inc. at their Birmingham, Alabama location.

Why This Matters

The presence of foreign metal particulate matter in a sterile pellet intended for medical use poses a risk of irritation or injury at the administration site. Ensuring the purity of sterile medications is critical for patient safety.

Source

Information provided by the FDA under Recall Number D-0311-2026.

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 1,699 Estradiol sterile pellets after discovering 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.