Accord Healthcare Inc. is voluntarily recalling 1 lot of Hydrochlorothiazide Tablets USP, 12.5 mg, at the consumer level, due to a potential labeling mix-up. According to the company, the lot (PW05264) of 100-count bottles of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg.

Accord was made aware of the issue with Lot PW05264 through a product complaint reported from a pharmacy. Based on findings of both preliminary and interim investigations carried out at the manufacturing site, company officials said, in a press release, that it believes no other lots of Hydrochlorothiazide Tablets are involved in this mix-up. 

Hydrochlorothiazide tablets are indicated in the management of hypertension, either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of the condition. Spironolactone tablets are indicated in the management of 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, severe heart failure.

Use of spironolactone tablets instead of hydrochlorothiazide tablets, poses the risk of contracting increased potassium levels in certain individuals, resulting in adverse events that range from limited health consequences to life-threatening situations in certain individuals. To date, Accord has not received any reports of adverse events related to the recall of Lot PW05264.

Accord's Hydrochlorothiazide Tablets USP 12.5 mg are light orange to peach colored, round, biconvex tablets debossed with H on one side and 1 on another side. The company is encouraging consumers in possession of Accord Hydrochlorothiazide that does not match the description, or who are unsure, to return with it to their pharmacy or consult a health care provider for confirmation.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.


Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 mg due to labeling mix-up [news release]. Durham, NC; Augusgt 27, 2018: Accord Healthcare. Accessed August 28, 2018.