Macleods Pharma Recalls 3,744 Bottles of Blood Pressure Meds Over Dissolution Failures
The FDA has classified a nationwide recall of over 3,700 bottles of a generic triple-combination blood pressure medication as Class II. Manufactured by Macleods Pharma USA, the affected lots failed dissolution testing, meaning the pills may not release active ingredients properly. Patients are advised to check lot numbers and consult their doctors before stopping treatment.
Key points
- Macleods Pharma USA initiated a voluntary recall on October 7 for 3,528 30-count bottles and 216 90-count bottles of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide tablets.
- The FDA classified the action as a Class II recall on October 26, indicating that use of the medication may cause temporary or medically reversible adverse health consequences, though serious harm is considered remote.
- The recall was triggered because the affected lots failed dissolution specifications, meaning the pills did not dissolve as required during federal quality testing.
- Affected lots include 12251163A (NDC 33342-246-07) and 12251163B (NDC 33342-246-10), both with an expiration date of May 31, 2027.
- The recall follows a September withdrawal of 13,567 bottles of chlorthalidone tablets by Inventia Healthcare Ltd. for similar dissolution testing failures.
Background
This recall is part of a broader trend of quality control issues in generic blood pressure medications. In late October, the FDA recalled over 21,000 bottles of Mylan Pharmaceuticals' telmisartan and amlodipine combination due to excessive potency. Additionally, a separate October recall involved Viatris telmisartan tablets. These events highlight ongoing scrutiny of generic drug manufacturing standards.
Why it matters
Patients relying on these specific generic combinations for hypertension management may experience inconsistent drug delivery if they continue using affected lots. While the FDA advises against abruptly stopping medication, the potential for suboptimal therapeutic effects necessitates prompt consultation with healthcare providers to ensure uninterrupted blood pressure control.
What to watch
Macleods Pharma USA has not provided public comment on the recall. Consumers should verify their bottle lot numbers against the FDA list and contact their pharmacists or doctors for replacement prescriptions if affected. The recall remains active nationwide.
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