Spironolactone is used to manage primary hyperaldosteronism and edematous (or swelling) conditions for patients with congestive heart failure, cirrhosis of the liver, nephrotic syndrome, essential hypertension or hypokalemia, according to the FDA.
Accord’s hydrochlorothiazide tablets USP 12.5mg, are light orange with an H on one side and the number 1 on the other.
The recall is specific to the individual lot number PW05264.
The company was alerted to the problem after a pharmacy reported it, the FDA said.
If someone takes a spironolactone tablet instead of a hydrochlorothiazide one, they could have increased potassium levels that could impact their health or even lead to life-threatening situations, according to the FDA.
Consumers with questions can contact Accord at 1-855-869-1081 or via email at rxrecalls @inmar.com.
If you have taken the mislabeled medication, you can contact the FDA at this link.
Earlier this year, the FDA announced, and eventually expanded, the recall of
Torrent Pharmaceuticals Limited's valsartan/amlodipine/hydrochlorothiazide tablets after trace amounts of N-nitrosodimethylamine (NDMA) were found in one of the drug's active ingredients.