Macleods Pharma USA has recalled two lots of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in the 40 mg / 10 mg / 12.5 mg strength. If you take this combination for high blood pressure, look for lot 12251163A or 12251163B. If the lot is missing from your pharmacy label or either number matches, call the pharmacy that filled your prescription. Ask it to check the lot and advise you on your next dose before you change how you take the medication. FDA enforcement record · FDA guidance for patients
Taken Social graphic based on FDA recall D-0077-2027.
Which olmesartan, amlodipine and hydrochlorothiazide lots are recalled?
The FDA’s record identifies these manufacturer packages. Both lots expire May 31, 2027.
| Bottle size | Lot number | National Drug Code | Bottles listed |
|---|---|---|---|
| 30 tablets | 12251163A | 33342-246-07 | 3,528 |
| 90 tablets | 12251163B | 33342-246-10 | 216 |
Macleods began the voluntary recall on October 7, 2026. The FDA classified it as Class II on October 26. The enforcement record identifies 3,744 bottles distributed nationwide in the United States under recall number D-0077-2027. To check another strength or a bottle from a different manufacturer, use its own lot information. FDA event 100113
Why Macleods recalled the tablets
The tablets failed a dissolution test. This quality check measures how a tablet releases its active ingredients under controlled conditions. The FDA classifies a recall as Class II when use may lead to temporary or reversible health effects, or when the chance of serious harm is remote. FDA recall details · FDA recall classifications
What to do if you take this medication
Have your prescription number and bottle handy when you call. If the pharmacy dispensed your pills in its own container, ask whether it can verify the manufacturer and lot from its dispensing records. The count on your prescription can differ from the size of the original manufacturer bottle.
If your supply is affected, ask how to get a replacement and what to do with your current tablets. FDA guidance says patients can generally continue taking medicines subject to Class II recalls unless directed otherwise by the company or FDA. Your pharmacist or prescriber can give instructions for your prescription. FDA’s drug recall guidance
