Estradiol Pellets Recalled Due to Metal Particulate Contamination
Asteria Health is recalling 1,475 units of Estradiol 20 mg pellets nationwide due to potential metal particulate matter contamination. Patients should contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II metal particulate contamination in a sterile drug product presents a risk of harm to patients. However, the source text does not report any illnesses or injuries, keeping the severity at the maximum level of 3 per the rubric for theoretical hazards without reported injury.
Plain-English summary
Asteria Health is recalling 1,475 sterile estradiol pellets (Lot 253000124, expiring 06/02/2026) distributed nationwide in the United States. The recall was issued because the product may contain metal particulate matter, a foreign substance that could pose a health risk if administered.
The affected product is Estradiol 20 mg, 1 Sterile Pellet with NDC 79559-3020-32. The manufacturer, F.H. Investments, Inc. (dba Asteria Health), located at 432 Industrial Lane, Birmingham, AL 35211, initiated the recall after identifying the potential contamination.
If you have received this product, do not use it. Contact your healthcare provider or pharmacist immediately for guidance.
The recalled product
- Product
- ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
- Manufacturer
- F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Category
- Drug
- Hazard
- metal-particulate
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 253000124
- Exp. 06/02/2026.
Distribution
Distributed nationwide across the United States.
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