MACLEODS PHARMA USA, INC recalls Olmesartan Medoxomil
- Recalling company
- MACLEODS PHARMA USA, INC
- Product
- 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
- Reason
- Failed Dissolution Specifications.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 7, 2026
- Reported
- Nov 4, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 3528 30-count and 216 90-count bottles
- Lot / codes
- Lot #: a) 12251163A, Exp 05-31-2027; b) 12251163B, Exp 05-31-2027
- Company location
- Princeton, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0077-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0077-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.