Recall: Hydrochlorothiazide (HCTZ) Capsules

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
Posted on

Generic manufacturer American Health Packaging has issued a voluntary recall of two lots of hydrochlorothiazide, a diuretic (sometimes known as a “water pill”) used to treat water retention or high blood pressure.

This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.

Who can recall a drug?

A manufacturer can voluntarily recall their medication or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled two lots of hydrochlorothiazide 12.5 mg capsules. You should note that this only applies to the American Health Packaging generic.

Why has hydrochlorothiazide been recalled?

The recall was initiated because some hydrochlorothiazide 12. mg capsules may contain extraneous particulate matter. This means there may be other ingredients or substances in the capsules that are not supposed to be there.

When was the recall initiated?

The affected lots of hydrochlorothiazide were recalled by the manufacturer on November 3, 2015.

Are patients who have taken this medication being notified?

No. This is a class II recall, which means that it isn’t necessary to notify you unless your doctor believes it may have an effect on your health.

If you have concerns that your prescription may be affected, contact your doctor or your pharmacist.

Which products were affected?

In this recall, two lots from one manufacturer are affected.

Drug: hydrochlorothiazide 12.5 mg capsules, 100-count bottle
Manufacturer: American Health Packaging
Lots: 151379 and 151380, expiration 12/31/2016
National Drug Code (NDC): 68084-0398-01

Are there other generic hydrochlorothiazide options not affected by the recall?

Yes. Several other companies make hydrochlorothiazide 12.5 mg capsules, and only the lots listed above have been recalled. If your current prescription has been affected, check with your pharmacy to see if they can get you a replacement.

Drugs featured in this story

Filed under