Several recalls on blood pressure medications have taken place in recent months, largely due to deviations from product quality standardsin one case, when a pharmacist who was filling a script reported the discovery of metal fragments that evidently had been packaged with the drug.
The nearly 120 million Americans whom national sources suggest have been diagnosed with high blood pressure may want to be aware of another blood pressure medication recall.
According to the U.S. Food and Drug Administration (FDA), Amneal Pharmaceuticals LLC of Bridgewater, NJ has recalled 858 bottles of Phenoxybenzamine Hydrochloride Capsules that were filled in what appear to be generic prescription bottles (though it’s said the drug is sold under names such as Dibenzyline and Dibenyline). The company (which in December 2024 appears to have been involved in federal legal action for an issue related to branding and patenting, though it’s not clear whether this matter is related) announced the recall after they discovered that the drugs contained impurities of an undisclosed nature.
The affected items were sold in 100-count bottles of 10-milligram (mg) capsules. Their packaging bears the National Drug Code (NDC) 60219-1502-01, as well as the following identifying information:
- Lot Number: AM221153, Exp. date: June 30, 2024
- Lot Number: AM230497, Exp. date: February 29, 2025
Note that 2025 is not a leap year and that the latter date appears to have been written in error.
These prescription-only hypertension medications are known as alpha blockers. The Cleveland Clinic explains that they work “by partially blocking the way some cells in your body receive instructions” via the endocrinological system. “They do this by blocking alpha-receptors, which are found on cells in specific areas or organs in your body … Because many of those cells line your blood vesselscontrolling how wide or narrow those vessels arekeeping them relaxed lowers your blood pressure,” Cleveland Clinic experts explain.
Alpha blockers may not be considered a first-line treatment for high blood pressure. Instead, alpha blockers are commonly used together with other medicines when high blood pressure is difficult to control. Over 10 million Americans are living with treatment-resistant hypertension, a 2018 report from the American Heart Association (AHA) estimated.
The FDA has designated this as a Class II recall, defined as “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” However, if you have the affected drugs in your home, contact your doctor or pharmacist to discuss replacing your prescription.
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