Macleods Pharma Levofloxacin Tablets Recall: Embossing Mismatch Risk
Macleods Pharma USA recalls 50-count Levofloxacin 500mg tablets due to embossing mismatch with package inserts. This may cause confusion in identifying the correct medication.
Lower-risk recall
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Contact the company
What happened, in plain English
Macleods Pharma USA is recalling 50-count bottles of 500mg Levofloxacin tablets because the embossing on the tablets doesn't match what's listed in the package insert. This mismatch could lead to confusion about which medication you have, potentially causing incorrect use. Read more at govinfonow.com/recall/34015-macleods-pharma-levofloxacin-tablets-recall-embossing-mismatch-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/34015-macleods-pharma-levofloxacin-tablets-recall-embossing-mismatch-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0162-2023
Cite this page
“Macleods Pharma Levofloxacin Tablets Recall: Embossing Mismatch Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34015-macleods-pharma-levofloxacin-tablets-recall-embossing-mismatch-risk. Based on FDA recall #D-0162-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0162-2023%22&limit=1).
Why it’s dangerous
The embossing on the tablets (T7) does not match the embossing (ML63) mentioned in the package insert. This mismatch could cause confusion about which medication is being used, potentially leading to incorrect medication administration.
Who’s affected
People who have the 50-count bottles of 500mg Levofloxacin tablets prescribed by a doctor. Those most at risk are individuals who might mistake these tablets for another medication due to the embossing mismatch.
How to tell if you have this one
Check for 50-count bottles of 500mg Levofloxacin tablets with the embossing T7 on the tablets and ML63 in the package insert. These were manufactured by Macleods Pharmaceuticals Ltd. in India and distributed by Macleods Pharma USA, Inc. in Princeton, NJ.
- Brand
Macleods Pharma- Category
Drug
What to do — step by step
Check Product Details
Verify the embossing on the tablets (T7) matches the package insert embossing (ML63) to confirm you have the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within United States and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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 should I do if I have the recalled product?
The recall does not require immediate action, but you should check the embossing to confirm you have the recalled product. If you are unsure, contact your doctor or pharmacist.
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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-0162-2023 (January 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0162-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.