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health
Notable (5/10)
Event date: October 26, 2026 ·
Macleods Pharma Recalls Thousands of Bottles of Blood Pressure Tablets That Failed Dissolution Testing
New Jersey-based Macleods Pharma USA is recalling two lots of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets after the pills failed dissolution testing, according to the U.S. Food and Drug Administration.
The company initiated the recall Oct. 7. The FDA classified it Oct. 26. The recall remains ongoing and affects product distributed nationwide.
What is being recalled
The recall covers two lots:
- 3,528 bottles of 30-count tablets from lot 12251163A, NDC 33342-246-07
- 216 bottles of 90-count tablets from lot 12251163B, NDC 33342-246-10
Both lots expire May 31, 2027.
Patients can find the lot number and National Drug Code on the prescription bottle or its label. If the numbers match, the pills are part of the recall.
Why the FDA flagged it
The FDA listed the reason as "failed dissolution specifications." In plain terms, the pills did not dissolve as required during testing.
The FDA classified the action as Class II. By the agency's definition, that means use of the affected medication "may cause temporary or medically reversible adverse health consequences," while the likelihood of serious health consequences is considered remote.
Macleods Pharma USA could not immediately be reached by Fox Business for comment.
Another dissolution recall in recent weeks
The Macleods recall comes weeks after another blood pressure medication was pulled over a similar issue.
India-based Inventia Healthcare Ltd. recalled 13,567 bottles of 25-milligram chlorthalidone tablets in September after the medication failed dissolution testing, according to the FDA. Chlorthalidone is used to treat high blood pressure and fluid retention, according to Mayo Clinic.
The FDA's timeline for Inventia is longer than one September action. The company recalled certain chlorthalidone lots in June. On Sept. 3, it initiated a separate recall involving an additional lot, and the FDA classified that one Class II on Sept. 17.
The two recalls involve different companies, different drugs and different lots. The shared reason, a dissolution failure, is the overlap.
What patients should do
Check the lot number and NDC on any olmesartan, amlodipine and hydrochlorothiazide prescription. Patients with a matching bottle should contact their pharmacy or prescriber.
Don't stop a blood pressure medication on your own without talking to a doctor or pharmacist.
The recall remains ongoing.
Sources used for this briefing
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