FDA Recalls Macleods Blood Pressure Tablets After Quality Test Failure
The FDA classified a nationwide recall of two lots of blood pressure tablets made by Macleods Pharma USA as Class II after the pills failed dissolution…
Macleods Pharma USA is recalling two lots of blood pressure tablets nationwide after the pills failed quality testing, the U.S. Food and Drug Administration said. The FDA classified the recall as Class II on Oct. 26, 2026, meaning use of the affected medication may cause temporary or medically reversible health consequences.
The recall covers 3,528 30-count bottles from lot 12251163A and 216 90-count bottles from lot 12251163B. Both lots expire May 31, 2027, and consumers can compare the lot number and National Drug Code on their prescription bottles with the recalled products.
The medication combines Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide. Testing found the pills did not dissolve as required, a failure that led to the recall by the New Jersey-based company.
Which bottles are included in the FDA recall?
The affected 30-count bottles carry NDC 33342-246-07, while the 90-count bottles carry NDC 33342-246-10. The FDA’s Class II classification describes a recall in which the product may cause temporary or medically reversible health consequences; the likelihood of serious consequences is considered remote.
Check the label carefully. The lot number distinguishes the recalled bottles from other products, while the NDC identifies each bottle size. The recall affects products distributed nationwide, so the location where a prescription was filled does not by itself rule out a match.
That matters for people who rely on the tablets to manage high blood pressure: a bottle matching the listed lot numbers is part of the recall, while the agency’s classification describes the potential health consequences. The FDA said the quality issue was a failure to meet dissolution specifications, not a result that the pills dissolved too quickly.
What testing found
The recall began on Oct. 7, 2026, and the FDA assigned its Class II rating on Oct. 26. The enforcement report said the tablets failed to dissolve as required during testing, the quality standard at the center of the action.
The same type of testing issue had also prompted action involving chlorthalidone tablets made by Inventia Healthcare. The FDA classified a separate September recall involving an additional lot as Class II on Sept. 17, 2026; the company had initiated that recall on Sept. 3.
For Macleods Pharma USA’s recalled products, the FDA’s listed lots are 12251163A and 12251163B. Both expire May 31, 2027.
