Macleods Pharma Recalls Blood Pressure Tablets Due to Dissolution Failure
Macleods Pharma USA recalls specific lots of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide tablets due to failed dissolution specifications.
Use caution until it’s fixed
Failed Dissolution Specifications.
What happened, in plain English
Macleods Pharma USA is recalling specific lots of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets because they failed dissolution specifications. This means the medication may not release its active ingredients properly, potentially reducing its effectiveness in treating high blood pressure. The recall affects 30-count and 90-count bottles distributed nationwide. Read more at govinfonow.com/recall/2084745-macleods-pharma-usa-inc-recalls-olmesartan-medoxomil-amlodipine-and-hydrochlorothiazide.
Source Summary by GovInfoNow · govinfonow.com/recall/2084745-macleods-pharma-usa-inc-recalls-olmesartan-medoxomil-amlodipine-and-hydrochlorothiazide · Published November 10, 2026 · Updated November 11, 2026 · FDA enforcement record: FDA #D-0077-2027
Cite this page
“Macleods Pharma Recalls Blood Pressure Tablets Due to Dissolution Failure.” GovInfoNow, updated November 11, 2026. https://govinfonow.com/recall/2084745-macleods-pharma-usa-inc-recalls-olmesartan-medoxomil-amlodipine-and-hydrochlorothiazide. Based on FDA recall #D-0077-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0077-2027%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, which is a quality control test ensuring the drug breaks down and releases its ingredients in the body at the right rate. If the medication does not dissolve correctly, patients may not receive the full dose needed to manage their blood pressure effectively.
Who’s affected
Patients currently taking this specific combination blood pressure medication from Macleods Pharma USA are affected. Individuals who purchased the recalled lots may receive a treatment that does not work as intended, posing a risk of uncontrolled hypertension.
How to tell if you have this one
Check your medication bottle for the National Drug Code (NDC) numbers 33342-246-07 (30-count) or 33342-246-10 (90-count). Verify the lot numbers are 12251163A or 12251163B, both with an expiration date of 05-31-2027. The product is labeled 'Rx Only' and manufactured for Macleods Pharma USA, Inc.
- Brand
Macleods Pharma- Category
Drug
What to do — step by step
Check Your Medication
Verify if your bottle matches the NDC numbers 33342-246-07 or 33342-246-10 and lot numbers 12251163A or 12251163B.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider immediately to discuss alternative treatment options if you have the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0077-2027 (October 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0077-2027 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on November 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.