Amlodipine blood pressure drug recalled
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The gist
Macleods Pharma USA recalled 3,744 bottles of a blood pressure tablet after the pills failed dissolution testing.
The FDA rated it Class II, so patients can generally keep taking it.
Background
Macleods Pharma USA is a New Jersey-based drug company that manufactured and recalled the tablets. The recalled product is a combination prescription tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide that relaxes blood vessels to lower blood pressure. The FDA listed the reason as "failed dissolution specifications," meaning the pills did not dissolve properly during testing, and classified the recall Class II. The recall comes weeks after another blood pressure medication was pulled from shelves over a similar issue.
How it unfolded
- Oct 7, 2026Macleods Pharma USA initiated a voluntary recall of certain lots of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets.
- Oct 26, 2026The FDA classified the recall as Class II in an enforcement report.
- Nov 2, 2026Fox Business reported thousands of bottles were recalled nationwide; WUSA9 reported the bottles were affected because the medicine could be ineffective.
- Nov 3, 2026Outlets reported the recall covers 3,528 30-count bottles from lot 12251163A and 216 90-count bottles from lot 12251163B, both expiring 31 May 2027, distributed nationwide.
Key terms
- dissolution testing
- A laboratory test measuring how fast a drug dissolves from a tablet, used for quality control and development.
- olmesartan medoxomil
- A prodrug form of olmesartan, an angiotensin II receptor blocker used to treat high blood pressure.
Source: Wikipedia
Who’s saying what
- Official
- The FDA listed the reason as "failed dissolution specifications" and said Class II means ingesting the medication may cause temporary adverse health consequences but is not likely to cause serious health problems.
- Official
- The FDA said that for Class II recalls, patients can generally continue taking the medicine unless the recalling company provides other instructions.
Still unverified
Macleods did not respond to a Newsday request for comment and did not confirm whether any recalled drugs were shipped to Long Island.