AvKARE Inc. has voluntarily recalled 397 bottles of Telmisartan and Amlodipine (80 mg/5 mg) prescription blood pressure medication. The recall was initiated because the tablets failed long-term stability testing due to impurity and degradation levels that exceeded approved specifications. This issue was discovered during an 18-month manufacturer stability study and affects two specific lots distributed in Arizona and Colorado.
The presence of impurities or degradation products above the established limits may reduce the effectiveness of the medication or result in unintended side effects over time. While the risk level is currently classified as low, consistent failure to meet quality standards means the product may not perform as intended for its entire shelf life.
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Sources: FDA iRES · Raw API Response
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