Taytulla Birth Control Pill Recall Issued Over Pregnancy Risk

Women given sample packs of the birth control pill Taytulla may face an increased risks of unintended pregnancy, due to a manufacturing defect that caused the pills to be packaged out of order. 

The FDA announced a Taytulla recall on May 29, warning that some placebo capsules were placed in the incorrect spot in sample packs, causing the birth control pills to fail to protect against pregnancy.

Taytulla (norethindrone acetate and ethinyl estriadol) is an oral contraceptive manufactured by Allergan. The company indicates that it received a physical report of the pills being packaged out of sequence in some sample packs.

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In some Taytulla sample packs, the first four days of the birth control pills were non-hormonal placebo pills, instead of active capsules, which means that the first four days a woman uses the month-long regimen, she is not actually protected against unintended pregnancy. Additionally, Allergan noted that since the problem occurred in sample packs, the reversed order of the pills may not be immediately apparent, since they are typically given to new users.

The recall affects Taytulla Softgel Capsules 1mg/20 mcg 6×28 Sample packs. They are 28-count blister cards with 24 pink softgel capsules with “WC” printed on the outer shell in white. These are the active capsules. There are also four maroon softgel capsules, also printed with “WC” which are the placebo pills. The recalled packs have a lot number of 5620706 and an expiration date of May 2019. They have been on the market since August 27, 2017. The pills were distributed to healthcare providers nationwide.

The company has issued recall letters to all of its customers, asking for a return of all the recalled sample packs from lot #5620706 with a May 2019 expiration date.

Consumers with questions can contact Allergan by calling 800-678-1605. Consumers or health care providers who have experienced adverse events or quality problems with the recalled birth control pill are encouraged to file a report with the FDA’s MedWatch Adverse Event Reporting Program.

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