Reported Nov 4, 2026 · Ongoing
Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5mg, packaged as a) 30-count bottle,…
Macleods Pharma USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MACLEODS PHARMA USA, INC · 103 College Rd E Fl 2 · Princeton, NJ · 08540-6611
Is this the product you have?
- 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 forMacleods Pharma USA, Inc. Princeton, NJ 08540
- Manufactured byMacleods Pharmaceuticals Ltd, Daman, 396210, India
- Lot codes and dates
Lot #: a) 12251163AExp 05-31-2027b) 12251163BExp 05-31-2027
- Amount recalled
- 3528 30-count and 216 90-count bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications.
This product could cause temporary or reversible health problems — stop using it.
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