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FDA Issues a Recall of the Popular High Blood Pressure Drug Hydrochlorothiazide

Another day, another drug recall from the Food and Drug Administration (FDA) due to a potentially deadly mixup. Accord Healthcare, Inc. is voluntarily recalling a single lot of mislabeled 100-count bottles of hydrochlorothiazide 12.5 mg tablets. Hydrochlorothiazide is used to treat hypertension, also known as high blood pressure. If used incorrectly, the effects could be life-threatening.

Bottles of 100 tablets of hydrochlorothiazide were incorrectly labeled and instead contained 100 25 mg tablets of spironolactone, according to a patient complaint made through a pharmacy. Spironolactone can also be used to treat high blood pressure, but the FDA warns that use of spironolactone tablets instead of hydrochlorothiazide tablets poses the risk of contracting hyperkalemia, an increase in potassium levels that be life-threatening to certain individuals. It is also possible that taking spironolactone instead of hydrochlorothiazide can have limited consequences, but as with any product recall, there is no reason to roll the dice.

A single lot of the drug, PW05264, is being recalled. Accord is also reaching out to pharmacists and retailers, as well as wholesalers and distributors.

So far, there have been no reports of anyone getting sick. But consumers and pharmacists are encouraged to contact Accord Healthcare by phone at 1-855-869-1081 from Monday to Friday during business hours 8 a.m. to 5 p.m. Eastern time, or by email at rxrecalls@inmar.com.