AvKARE recalled 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets on September 2, 2025. The tablets failed content uniformity specifications, posing a high hazard risk. Consumers should stop using the product immediately and consult their healthcare provider.
Failed Content Uniformity Specifications
Consumers and healthcare providers should stop using this product immediately. Contact AvKARE or your healthcare provider for guidance. Notification method: Letter
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The recalled products include Norgestimate and Ethinyl Estradiol Tablets, USP, in three strengths: 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg. They were distributed nationwide in the U.S. The affected lot number is LF41138A, with an expiration date of June 30, 2027.
The recall stems from a failure to meet content uniformity specifications. This failure can result in inconsistent dosing, leading to potential health risks.
No specific incidents, injuries, or deaths have been reported in connection with this recall. The risk remains high due to the nature of the dosage inconsistency.
Consumers should stop using the recalled tablets immediately. Contact AvKARE or your healthcare provider for guidance and further information.
For more information, call AvKARE at 1-800-XXXX-XXXX. Additional details can be found at the FDA's recall page.
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