Heritage Pharmaceuticals Inc. has recalled 7,176 bottles of Felodipine Extended Release Tablets, USP 10 mg (generic for Plendil), a medication used to treat high blood pressure. The recall was initiated because routine testing discovered that a specific impurity, known as Felodipine Related compound A, exceeded acceptable safety limits during stability checks. These 100-count bottles were distributed nationwide in the United States and can be identified by NDC 23155-050-01.
The presence of impurities above approved levels can potentially lead to unexpected side effects or reduced effectiveness of the medication over time. While this is a low-risk (Class III) recall, the long-term consumption of degradation products beyond specified limits is not recommended for patient safety.
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Sources: FDA iRES · Raw API Response
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