Olmesartan Medoxomil recall (MACLEODS PHARMA USA, INC)
DrugClass IIOngoing
Summary: MACLEODS PHARMA USA, INC is recalling 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, Dam. Reason: Failed Dissolution Specifications.
What is being recalled
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
Why
Failed Dissolution Specifications.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot #: a) 12251163A, Exp 05-31-2027; b) 12251163B, Exp 05-31-2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0077-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | October 7, 2026 |
| Reported | November 4, 2026 |
| Company | MACLEODS PHARMA USA, INC |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3528 30-count and 216 90-count bottles |
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