Ascend Laboratories recalled 8,568 bottles of Amlodipine and Olmesartan Medoxomil Tablets on July 21, 2025. The recall follows reports of low dissolution results, impacting the drug's effectiveness. Consumers should stop using the product and seek guidance immediately.
Failed Dissolution Specifications: low dissolution results
Consumers and healthcare providers should stop using this product immediately. Contact Ascend Laboratories, LLC or your healthcare provider for guidance. Notification method: Letter
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The recall involves Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, sold in 30-count bottles. The product carries NDC 67877-501-30 and has an expiration date of April 30, 2026.
The recalled tablets failed dissolution specifications, which may affect their intended therapeutic effect. Low dissolution results can lead to inadequate treatment of hypertension.
No specific injuries or adverse events are reported related to this recall. However, the risk of ineffective treatment poses a significant health concern.
Consumers should stop using the recalled tablets immediately. Contact Ascend Laboratories, LLC or a healthcare provider for further instructions.
For assistance, call Ascend Laboratories, LLC at their customer service number. More information is available on the FDA website.
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