FDA-Drug2026-02-18Class IIPROCESSING DEFECT

Asteria Health estradiol pellets recalled for potential metal particulate matter

METALNationwide distributionDrugs

What this means

Asteria Health estradiol 15 mg pellets may contain metal particulate matter, a foreign substance that could pose a health risk. The FDA has identified four affected lot numbers distributed nationwide. No injuries have been reported to date.

  • Check your estradiol pellets against the lot numbers: 253000118, 253000145, 253000146, or 253000167.
  • Stop using the product if you have one of these lots.
  • Contact your healthcare provider or pharmacist for instructions on what to do next.
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The agency's original wording
Hazard

Presence of Foreign substance - potential presence of metal particulate matter

Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
14,848 pellets
Manufactured in
432 Industrial Ln, N/A, Birmingham, AL, United States
Products
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0310-2026

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