Glenmark Pharmaceuticals recalled 26,928 packs of Viorele oral contraceptives on September 3, 2025. The recall follows the discovery of impurity issues in the product. Consumers should stop using the affected tablets immediately and contact healthcare providers for guidance.
Failed Impurities/Degradation Specifications
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
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The recalled product is Viorele, containing Desogestrel and Ethinyl Estradiol, with dosages of 0.15 mg/0.02 mg and 0.01 mg. Each pack consists of three blisters, each containing 28 tablets. The product was distributed across the United States.
The recall was initiated due to failed impurities and degradation specifications. These issues can potentially compromise the safety and efficacy of the medication, posing a risk to consumers.
There are no reported incidents or injuries associated with the use of the recalled product. Consumers are advised to take immediate action, as the failure of specifications can lead to health risks.
Consumers should stop using Viorele tablets immediately. Contact Glenmark Pharmaceuticals Inc. or your healthcare provider for further guidance and potential return options.
For more information, contact Glenmark Pharmaceuticals at their official website or by phone. Additional details can be found at the FDA recall page.
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