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FDA announces nationwide birth control pill recall: nearly 27,000 packages 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 drug due to “impurity/degradation non-compliance specifications,” meaning the birth control may contain unintended chemicals or may have broken down from its original form. The medicine in question may have safety, quality or effectiveness issues.

On October 15, the FDA assigned the recall a Class II risk level, stating that the birth control “may cause temporary or medically reversible adverse health consequences,” or that the risk of serious health consequences is “low.”

The recall involves 26,928 packets of Viorele, a prescription-only combined contraceptive 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 blister packs each containing 28 tablets.
  • Batch number: 20230733
  • Expiry date: October 2025

The FDA did not provide specific instructions for this recall, but noted that it is still in progress. As a Class II recall, the safest option is to not take the affected contraceptive and contact your doctor or pharmacy for a replacement.

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