Fagron, Inc. is recalling approximately 934 grams of Estriol powder used for prescription compounding because the manufacturer of the active ingredient did not follow proper quality assurance and manufacturing standards. This recall affects four different bottle sizes (1 gram, 5 gram, 25 gram, and 100 gram) of Estriol distributed nationwide in the USA. Because this product is a raw ingredient used by pharmacies to create customized medications, patients may have received it as part of a finished compounded prescription.
The lack of quality assurance at the manufacturing facility means the purity, strength, and safety of the ingredient cannot be guaranteed. Using a medication with incorrect potency or quality standards can lead to ineffective treatment or unexpected side effects.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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