Lack Of Potency Led To Generic Yaz Birth Control Pill Recall

Lack Of Potency Led To Generic Yaz Birth Control Pill Recall

Introduction

On July 23, FDA announced a recall on generic Yaz (drospirenone and Ethinyl estradiol) birth control pills sold by Jubilant Cadista Pharmaceuticals Inc. due to the risk of ineffective birth control, which may lead to unwanted pregnancies, even when taken as directed. 

According to the notice, the pills were ineffective as the absorption of the active ingredients was decreased, which left women with inadequate protection against becoming pregnant.

Ethinyl estradiol and drospirenone tablet is a generic estrogen/progestin combination oral contraceptive, widely used by women to treat symptoms of premenstrual dysphoric disorder, prevent pregnancy, and treat moderate acne.

The recall affected one lot of the generic Yaz pills distributed across the United States. It contains 3mg/0.01 mg packed in a carton with 3 blister cards, each card contains 28 film-coated, biconvex tablets with 24 round active pink tablets, and four inert while colored tablets. Lot number 183222 with NDC number 59746-763-43 and expiration date of 11/2020 was affected by the recall.  The company stated that they are notifying customers by email and sending a recall notification letter and response forms to return the product.

Yaz lawsuits were consolidated under MDL No. 2100, presided by Judge David R. Herndon in the Southern District of Illinois. As of January 2019, no cases are pending in the MDL.