FDA Announces Nationwide Recall of Birth Control Pills—Nearly 27,000 Packs Affected

Nearly 27,000 packs of the birth control pill Viorele have been recalled nationwide, according to the Food and Drug Administration (FDA).

In early September, Glenmark Pharmaceuticals voluntarily recalled the medication because of “failed impurities/degradation specifications,” which means the birth control may contain unintentional chemical substances or may have broken down from its original form. The affected medication may have issues with safety, quality, or efficacy.

On Oct. 15, the FDA gave the recall a Class II risk level, indicating that the birth control “may cause temporary or medically reversible adverse health consequences,” or the risk of serious health consequences is “remote.”

The recall affects 26,928 packs of Viorele, a prescription-only combination birth control pill, with the following information:

• Product description: Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg; 3 blisters each containing 28 tablets.
• Batch number: 20230733
• Expiration date: October 2025

The FDA didn’t provide specific instructions for this recall, but noted it is still ongoing. As a Class II recall, the safest option is not to take the affected birth control and to contact your healthcare provider or pharmacy for a replacement.