AvKARE recalled 2,192 cartons of Norgestimate and Ethinyl Estradiol tablets distributed nationwide. The recall cites failed content uniformity specifications. Consumers and healthcare providers should stop using this medicine immediately and contact AvKARE or a healthcare provider for guidance.
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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This medicine is a combined oral contraceptive used to prevent pregnancy. It combines estrogen and progestin and is available by prescription only.
The failure of content uniformity means tablets may not contain the correct amount of active ingredients, potentially leading to ineffective contraception or unintended pregnancy.
This recall is not described as part of a broader industry pattern.
Consumers may experience reduced efficacy or unanticipated pregnancy risk. The recall affects a relatively small number of cartons but requires immediate action from users and healthcare providers.
Packaging on carton and blister contains NDCs, lot number, and expiry date
Remedy processing timelines are not specified; expect guidance by mail and provider consultation within weeks
Keep packaging, take photos of the lot and NDC codes, document health concerns and communications with AvKARE or a clinician
Product: Norgestimate and Ethinyl Estradiol Tablets, USP. Dosages: 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, 0.25 mg/0.025 mg. Packaging: 3 Units, 3x28 tablets blister cards per carton. Form: Rx only. Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84. Blister NDC: 42291-565-28. Quantity recalled: 2192 cartons. Recall date: 2025-09-02. Status: Active. Hazard: Failed Content Uniformity Specifications. Remedy: Stop using the product. Contact AvKARE or your healthcare provider for guidance. Link: FDA enforcement report D-0007-2026. Lot numbers: LF41138A. Expiration: 06/30/2027. Route
No injuries or incidents have been reported.
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