A recall has been issued for some generic Yaz pills, due to a risk that the birth control may not be as effective as it should be, which could lead to unwanted pregnancies.
The FDA announced a generic Yaz birth control pill recall on July 23, indicating that drospirenone and ethanol estradiol tablets sold by Jubilant Cadista Pharmaceuticals Inc. may fail to prevent pregnancy, even when taken as directed.
The drospirenone and ethanol estradiol tablet birth control is a generic estrogen/progestin combination oral contraceptive, which has been widely used by women under the brand name “Yaz” to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder, and treat moderate acne.
According to the recall notice, the pills were not as effective as they should be because absorption of the active ingredients was decreased. This could leave women without adequate protection against becoming pregnant. However, Jubilant has not received any reports of adverse events related to the recall.
The voluntary recall affects one lot of the generic Yaz pills distributed across the United States. The 3 mg/0.01 mg birth control is packaged 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. They have a lot number of 183222 with NDC number 59746-763-43 and expiration date of 11/2020.
The generic Yaz birth control pills are sold by Jubilant Cadista Pharmaceuticals Inc. and manufactured by Cyndea Pharma, S.L., Olvega (Soria).
Jubilant says it is taking the steps to notify customers by emailing and sending a recall notification letter and response form and arranging for the product to be returned.
Customers who purchased the product directly from Jubilant Cadista can contact the company at 1-855-205-9246 to arrange for return. They can also contact 1-800-308-3985 for additional questions and concerns.
Adverse reactions or quality problems experienced with the use of the product should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Several years ago, Yaz and Yasmin birth control formulations led to thousands of product liability lawsuits as consumers alleged the products caused venous thromboembolism and gall bladder injuries. The main ingredient, drospirenone, has been linked to an increased risk of blood clots, heart attacks, strokes and other injuries.
Ultimately, Bayer agreed to pay at least $2 billion to settle about 10,000 claims.