FDA recall, , Moderate risk
Macleods Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets
Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets may not dissolve properly in the body.
Summary by Recall Canary from the FDA notice
What happened
Macleods Pharma USA, Inc., of Princeton, New Jersey, voluntarily recalled Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5mg because the product failed dissolution specifications. The recall began on October 7, 2026, and was added to the FDA's Enforcement Report on October 26, 2026.
The tablets were distributed nationwide in the USA and are packaged in 30-count and 90-count bottles. The product is manufactured for Macleods Pharma USA, Inc. and manufactured by Macleods Pharmaceuticals Ltd, Daman, 396210, India. Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC and lot code are listed under that product.
An NDC (National Drug Code) is usually printed on the drug's label.
Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5mg
- NDC
- 33342-246-07
- 33342-246-10
- Lot code
- 12251163A
- 12251163B
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Nationwide in the USA
- Recalled by
- MACLEODS PHARMA USA, INCPrinceton, New Jersey
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100113
- Recall number
- D-0077-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from MACLEODS PHARMA USA, INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
MACLEODS PHARMA USA began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
