Posted from: Monday, October 08, 2018 - 12:27 PM - Present

Hydrochlorothiazide Tablets Recalled

August 28, 2018 – Accord Healthcare has announced a voluntary recall of one lot of Hydrochlorothiazide Tablets, USP, 12.5mg. The recall is in response to incorrect labeling on some 100-count bottles of the product.

At least one 100-count bottle from Lot PW05264 has been found to contain Spironolactone Tablets USP 25mg instead of Hydrochlorothiazide Tablets. According to the manufacturer, no other lots have been affected by the labeling error.  The manufacturer became aware of the problem when a pharmacy filed a complaint regarding the mislabeled bottle.

Hydrochlorothiazide Tablets are indicated for the management of hypertension. The medication can be used alone, or it can be taken with other antihypertensive drugs to enhance their efficacy when treating severe forms of hypertension. In contrast, spironolactone tablets are used to treat primary hyperaldosteronism; edematous conditions for patients with congestive heart failure; cirrhosis of the liver accompanied by edema and/or ascites; nephrotic syndrome; essential hypertension; hypokalemia; and severe heart failure. Using spironolactone in place of hydrochlorothiazide could cause hyperkalemia (increased potassium levels) in some patients, which can be life-threatening.

Patients who are concerned their Hydrochlorothiazide Tablets may be impacted by the recall should check the label for the manufacturer name. If the tablets were manufactured by Accord, they should be round, light orange to peach in color, and marked with “H” on one side and “1” on the other. Patients can reach out to their pharmacy or healthcare provider if the tablets do not match this description, or if they are uncertain the medication is correct.

Accord Healthcare can be reached with questions regarding the recall by phone at 1-855-869-1081, by fax at 1-817-868-5362, or by e-mail at Adverse events that may be related to the recall should be reported to the patient’s healthcare provider, and can also be reported to the FDA’s MedWatch program.

The FDA has provided further details on its website at:

BeneCard PBF’s mail order pharmacy, Benecard Central Fill, was not impacted by the recall.

Last Updated Monday, September 16, 2019 - 06:47 PM.