Lupin Pharmaceuticals Inc. is recalling 12,464 cartons of Fayosim (levonorgestrel and ethinyl estradiol) tablets USP. This prescription birth control medication is being recalled because long-term stability testing found that some tablets contained levels of impurities and degradation products that exceeded approved safety specifications. Consumers who use this medication should be aware that the quality and consistency of the drug may be compromised. These products were distributed nationwide across the United States in extended-cycle wallets containing 91 tablets each.
The presence of out-of-specification impurities and degradation products means the medication may not meet its required quality standards over its intended shelf life, which could potentially affect the safety or efficacy of the treatment.
Healthcare consultation and pharmacy 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.
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Sources: FDA iRES · Raw API Response
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