Macleods Pharma Recalls Amlodipine/Olmesartan Tablets Due to cGMP Deviations
Macleods Pharma USA recalls specific lots of Amlodipine and Olmesartan Medoxomil tablets due to current Good Manufacturing Practice deviations.
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cGMP deviations
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What happened, in plain English
Macleods Pharma USA, Inc. is recalling specific lots of Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, in 30-count bottles. The recall was initiated because the product was manufactured with current Good Manufacturing Practice (cGMP) deviations. The record does not specify what these deviations are or if they affect the safety or efficacy of the medication. Read more at govinfonow.com/recall/35220-macleods-pharma-recalls-amlodipine-olmesartan-tablets-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/35220-macleods-pharma-recalls-amlodipine-olmesartan-tablets-due-to-cgmp-deviations · Updated October 10, 2026 · FDA enforcement record: FDA #D-0632-2022
Cite this page
“Macleods Pharma Recalls Amlodipine/Olmesartan Tablets Due to cGMP Deviations.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35220-macleods-pharma-recalls-amlodipine-olmesartan-tablets-due-to-cgmp-deviations. Based on FDA recall #D-0632-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0632-2022%22&limit=1).
Why it’s dangerous
The hazard is described only as 'cGMP deviations,' which means the manufacturing process did not meet federal quality standards. The record does not state what specific quality issues occurred or whether they pose a risk to patient health, so the exact danger mechanism is unknown based on this text.
Who’s affected
Consumers in the USA who purchased Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, manufactured by Macleods Pharmaceuticals, Ltd. Individuals taking this prescription medication for blood pressure management are most likely affected.
How to tell if you have this one
Check your medication bottle for the following details: Brand 'Macleods Pharma', NDC 33342-192-07, Lot number BAD62101A, and an expiration date of 2/2024. The product is a 30-count bottle containing Rx only tablets.
- Brand
Macleods Pharma- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for this product?
The National Drug Code (NDC) is 33342-192-07.
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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-0632-2022 (February 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0632-2022 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.