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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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.
The recall is due to the potential presence of foreign metal particulate matter. This contamination poses a serious health risk, as ingestion could lead to significant injury or adverse health effects.
There have been no specific incidents reported to date. The high hazard classification indicates a serious concern for consumer safety.
Stop using the Estradiol pellets immediately. Contact F.H. Investments, Inc. or your healthcare provider for guidance on how to proceed. Consumers should expect to receive notification letters regarding this recall.
For more information, contact F.H. Investments, Inc. at their official website or customer service number. Additional details can be found on the FDA enforcement report.
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