Fayosim Birth Control Recall Issued Over Tablet Specification Problems

Nearly 13,000 cartons of Fayosim birth control pills are being recalled because they do not meet specifications and could be less effective at preventing pregnancy than expected.

The FDA announced the Fayosim recall on March 22, indicating that the combination birth control pills failed an ingredient stability test, which may mean that women taking the pills face a risk of becoming pregnant without intending to.

Fayosim is a birth control product that combines levonorgestrel and ethanol estradiol, which are taken on a 90-day cycle, or three months at a time, to regulate a woman’s period. This often results in a woman having only four periods per 12 months. Fayosim can also be taken for other conditions such as to help reduce premenstrual symptoms, decrease the risk of ovarian cysts, and reduce acne.

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According to the FDA recall report, the pills were pulled from the market due to “Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01 mg at 12 month long term stability study.”.

The recalled Fayosim pills contain a combination of levonorgestrel and ethanol estradiol at strengths of 0.15 mg/0.02 mg, 0.15 mg/0.025 mg, and 0.15 mg/0.03 mg pills within the pack. Each package contains one extended-cycle wallet of 91 tablets with one pouch per carton. The recall includes lot number L800016 with an expiration of 12/2019 and lot number L800721 with and expiration date of 05/2020.

The recall affects more than 12,500 cartons manufactured by Lupin Ltd. at the Pithampur facility in Madhya Pradesh and distributed by Lupin Pharmaceuticals Inc. in Baltimore, Maryland.

This has been classified as a class II recall, which means the FDA believes use of the product or exposure to the product may cause “temporary or medically reversible adverse health consequences” or a remote risk of serious adverse health effects.

Women taking Fayosim should not stop taking the birth control pills, but should contact their doctor immediately to discuss replacing the pills or an alternative form of birth control. Backup contraceptive methods should also be used in the meantime to prevent unintended pregnancy.

Consumers can report any side effects linked to the use of recalled Fayosim to the FDA MedWatch Adverse Event Reporting Program.


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