Asteria Health Recalls Estradiol Sterile Pellets Due to Potential Metal Particulate Matter
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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 April 6, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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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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