Estradiol Pellets Recalled for Potential Metal Contamination
F.H. INVESTMENTS Inc. (dba Asteria Health) is recalling 2,442 Estradiol 25 mg sterile pellets nationwide due to potential metal particulate matter. Patients should contact their healthcare provider if they received these pellets.
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: This is an FDA Class II recall for potential metal contamination in a sterile injectable drug. Although the hazard could cause serious harm if metal particles are present, the source states 'potential presence' rather than confirmed contamination, and no illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, justifying a High rating.
Plain-English summary
F.H. INVESTMENTS Inc. (dba Asteria Health) is recalling one lot of Estradiol 25 mg sterile pellets nationally. The affected product is NDC 79559-3025-32, Lot# 253000136, with an expiration date of July 1, 2026.
The recall was initiated due to the potential presence of metal particulate matter in the product. No illnesses or injuries have been reported at this time.
Patients who have received these pellets should contact their healthcare provider immediately to discuss their treatment options. The manufacturer can be reached at Asteria Health, 432 Industrial Ln, Birmingham, AL 35211. The FDA is monitoring this recall.
The recalled product
- Product
- ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
- Manufacturer
- F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Category
- Drug — Hormone Pellet
- Hazard
- metal-particulate-matter
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#: 253000136
- Exp. 07/01/2026.
Distribution
Distributed nationwide across the United States.
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