The FDA has announced recalls involving commonly prescribed blood pressure medications, with thousands of bottles affected nationwide.
If you take either of these medications, it’s worth checking your bottle before taking your next dose.
The U.S. Food and Drug Administration says chlorthalidone tablets are being recalled after the manufacturer found they had “failed dissolution specifications.” Testing raised concerns that the tablets may not dissolve the way they are supposed to, potentially affecting how the medication is absorbed by the body.
The recall involves 25-milligram chlorthalidone tablets distributed across the United States by Risiong Pharma Holdings, Inc.
According to the FDA, abou 11,460 bottles are included in the recall. The affected products are:
100-count bottles: NDC 64980-599-01, batch RISA24001
1,000-count bottles: NDC 64980-599-10, batch RISB24002
Expiration date: 04/2027
Chlorthalidone is a commonly prescribed diuretic used to help control high blood pressure. It can also be prescribed to reduce fluid retention.
If your bottle matches the recall information, don’t simply stop taking the medication on your own. Contact your pharmacy or prescribing healthcare provider and ask about a replacement or another appropriate option.
The FDA has not yet classified this particular recall by severity.
Another blood pressure drug is also being recalled
The FDA also reported that Novartis voluntarily initiated a recall of Diovan (valsartan) 160 mg on August 4. The recall was announced by the agency on August 8.
Valsartan belongs to a class of medications known as angiotensin II receptor blockers, or ARBs. These drugs work by blocking a substance that causes blood vessels to tighten, helping lower blood pressure.
Valsartan is also used to treat heart failure and certain patients following a heart attack.
The Diovan recall involves:
Medication: Diovan (valsartan) 160 mg
Quantity: 90 tablets
Lot: AV5913C
Expiration: 06/2027
Prescription: Rx only
The medication was manufactured by Patheon Manufacturing Services in North Carolina and distributed by Novartis from its New Jersey operation.
Why were the tablets recalled?
The FDA says the Diovan recall was also triggered by “failed dissolution specifications.”
That doesn’t necessarily mean the medication is toxic or contaminated. Instead, the concern is that the tablets may not dissolve according to the specifications used to ensure the drug is properly absorbed.
The FDA classified the Diovan recall as a Class II recall on August 7.
That’s the agency’s middle-level recall category. It generally means exposure to the affected product could cause temporary or medically reversible health consequences, while the likelihood of a serious health problem is considered remote.
What should you do if you take one of these medications?
First, check the bottle rather than assuming your prescription is part of the recall. The specific lot and expiration information matters.
If your medication matches one of the recalled products, contact the pharmacy that filled your prescription or your healthcare provider for instructions and a possible replacement.
And as with any prescription medication recall, don’t abruptly stop taking a blood pressure medication without speaking with a healthcare professional first. Suddenly stopping certain medications can create its own health risks.
If you’ve already taken medication from an affected lot and are experiencing concerning symptoms, contact your healthcare provider promptly.
