International Laboratories recalls Clopidogrel tablets with simvastatin mix-up
International Laboratories recalls 75mg Clopidogrel tablets that were mislabeled with simvastatin 10mg. This mix-up could lead to incorrect medication use.
Lower-risk recall
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Contact the company
What happened, in plain English
International Laboratories is recalling Clopidog: 75mg tablets that were mislabeled as containing simvastatin instead of clopidogrel. This mix-up could cause someone to take the wrong medication. Read more at govinfonow.com/recall/40956-international-laboratories-recalls-clopidogrel-tablets-with-simvastatin-mix-up.
Source Summary by GovInfoNow · govinfonow.com/recall/40956-international-laboratories-recalls-clopidogrel-tablets-with-simvastatin-mix-up · Updated October 7, 2026 · FDA enforcement record: FDA #D-0472-2018
Cite this page
“International Laboratories recalls Clopidogrel tablets with simvastatin mix-up.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40956-international-laboratories-recalls-clopidogrel-tablets-with-simvastatin-mix-up. Based on FDA recall #D-0472-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0472-2018%22&limit=1).
Why it’s dangerous
The tablets were mislabeled with simvastatin (a cholesterol drug) instead of clopidogrel (a blood thinner). Taking simvastatin instead of clopidogrel could cause incorrect medication effects.
Who’s affected
People who have the 30-count bottles of Clopidogrel 75mg tablets labeled as Clopidogrel (NDC 54458-888-16) from International Laboratories. Those who take blood thinners like clopidogrel are most at risk.
How to tell if you have this one
Check for 30-count bottles labeled 'Clopidogrel Tablets, USP 75 mg' with NDC 54458-888-16. The lot number is 117099A and expires 08/19.
- Brand
International Laboratories- Category
Drug
What to do — step by step
Check Label
Look for the label that says 'Simvastatin tablets, USP 10 mg' instead of 'Clopidogrel tablets, USP 75 mg'.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class I
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
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-0472-2018 (January 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0472-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.