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Allergan Recalls Nearly 170,000 TAYTULLA Sample Packs

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On May 29, 2018, pharmaceutical company Allergan announced the recall of nearly 170,000 packets of Taytulla birth control capsules.  Allergan had distributed the contraceptives to doctors nationwide for use as free samples for patients. A manufacturing error caused the capsules to be placed out of order, increasing the risk of contraceptive failure and unintended pregnancy.

The FDA also posted an alert to let both patients and doctors know about the issue and encouraged both to report any adverse events associated with the pills to the administration’s MedWatch Adverse Event Reporting Program.

Taytulla Packaging Error Increases the Risk of Unintended Pregnancy

Taytulla is a combination birth control drug consisting of estrogen and a progestin hormone called ethinyl estradiol to prevent ovulation and pregnancy. The product’s blister packs include 28 capsules total, 24 capsules of which contain the active hormones and 4 capsules of which are inactive or placebo pills. The placebo capsules are meant to be taken at the end of the treatment sequence to allow for menstruation while also maintaining the patient’s habit of taking the medication daily.

Due to a manufacturing error, the 4 placebo capsules were placed as the first 4 capsules in the treatment sequence in certain blister packs. By taking the placebo pills at the beginning of her cycle, a woman’s risk of unintended pregnancy is significantly increased.

The Taytulla packs being recalled are Lot #5620706, Exp. May 2019. These capsules were sent to doctors nationwide between August 2017 and May 2018.

Consumers Need to Immediately Verify Whether Their Taytulla Packs Have Been Recalled

Women who received a Taytulla sample pack from their doctor should immediately verify that the product is not subject to the recall.

Allergan advises that women who have received a sample pack with the Lot #5620706, Exp. May 2019, notify their doctor for next steps. Consumers with questions about the recall may also call Allergan at 800-678-1605 between 8:00 a.m. and 8:00 p.m. EST, Monday through Friday.

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