Macleods Pharma USA recalls olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets over failed dissolution specifications
The tablets failed dissolution specifications, which the notice gives as the reason for the recall of 30-count and 90-count bottles sold nationwide in the USA.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Company
- Macleods Pharma USA, INC
- Hazard
- Failed Dissolution Specifications.
- Units
- 3528 30-count and 216 90-count bottles
- Where sold
- Nationwide in the USA
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 26, 2026
- Recall started
- October 7, 2026
- FDA enforcement report
- November 4, 2026
- Identifiers
- Codes: Lot #: a) 12251163A, Exp 05-31-2027; b) 12251163B, Exp 05-31-2027
- FDA recall number: D-0077-2027
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 for recall
- Failed Dissolution Specifications.
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 3528 30-count and 216 90-count bottles
Related recalls
Ascend Laboratories recalls amlodipine and olmesartan medoxomil tablets because they failed a dissolution test
The 10mg/40mg tablets, sold in 30-tablet bottles, were found to be out of specification due to dissolution, and 11,424 bottles were distributed nationwide within the United States.
Ascend Laboratories, LLC · 11,424 bottles.