Asteria Health recalled 22,478 Estradiol 12.5 mg pellets on January 26, 2026, due to potential metal particulate contamination. Consumers and healthcare providers must stop using the product immediately. The FDA classified this recall as Class II, indicating a high hazard level.
Presence of Foreign substance - potential presence of metal particulate matter
Consumers and healthcare providers should stop using this product immediately. Contact F.H. INVESTMENTS, Inc. (dba Asteria Health) or your healthcare provider for guidance. Notification method: Letter
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Estradiol pellets are used in hormone replacement therapy to treat symptoms of menopause and other hormonal imbalances. They provide a steady release of hormones into the body over time, making them a preferred option for many patients.
The potential presence of metal particulate matter in the pellets can occur during manufacturing or packaging processes. Ingestion of these particles could lead to serious health risks, including injury or adverse effects.
This recall is not part of a broader industry pattern.
Consumers should take immediate action to stop using the product, as the contamination poses significant health risks. This recall may cause inconvenience and concern for those relying on these pellets for hormone therapy.
Lot numbers are usually printed on the packaging or label of the product. Expiration dates are also printed on the same area.
Expect a refund processing timeline of 4-6 weeks after returning the recalled product.
Keep all receipts and correspondence regarding the recall for your records.
The recalled product is Estradiol, 12.5 mg, sold in sterile pellet form. The affected lot numbers include 253000117, 253000129, 253000130, 253000154, 253000155, and 253000160 with various expiration dates up to September 10, 2026. The product was distributed nationwide in the USA.
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