FDA-Drug2026-10-26Class IIPROCESSING DEFECT
Macleods Pharma Olmesartan/Amlodipine/Hydrochlorothiazide tablets recalled for failed dissolution
What this means
Macleods Pharma USA is recalling specific lots of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide combination tablets (40 mg/10 mg/12.5 mg) because they failed to meet dissolution specifications. This means the tablets may not break down properly in the body, potentially reducing how well the medication works.
- Check if you have lot 12251163A or 12251163B (expiring 05-31-2027) in 30-count or 90-count bottles.
- Do not stop taking your blood pressure medication without talking to your doctor or pharmacist.
- Contact your pharmacy or doctor for a replacement or alternative medication.
- Return the recalled medication to your pharmacy.
The agency's original wording
Hazard
Failed Dissolution Specifications.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
3528 30-count and 216 90-count bottles
Manufactured in
103 College Rd E Fl 2, Princeton, New Jersey, United States
Products
Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5mg, packaged as a) 30-count bottle, NDC 33342-246-07; b) 90-count bottle, NDC 33342-246-10; Rx Only, Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd, Daman, 396210, India
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0077-2027Want us to check the next one for you?
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