Asteria Health Recalls Estradiol Sterile Pellets Due to Potential Metal Contamination
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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 April 6, 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 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., 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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