International Laboratories Clopidogrel Tablets Recall (Class I)

Why it was recalled

LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.

Product description

Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16

Lot numbers, UPCs & expiration codes

Lot #: 117099A, Exp. 08/19

Where it was sold

Nationwide within the US

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0472-2018
Classification: Class I
Status: Terminated
Recall initiated: Jan 4, 2018
FDA report date: Feb 7, 2018
Quantity: 218772 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: International Laboratories, LLC

Original FDA data

Every field from FDA enforcement report D-0472-2018, exactly as published.

Show all FDA fields

City: Seminole
State: FL
Status: Terminated
Country: United States
Event ID: 78913
Address: 6950 Bryan Dairy Rd Ste A
Code information: Lot #: 117099A, Exp. 08/19
Postal code: 33777-1606
Report date: Feb 7, 2018
Product type: Drugs
Recall number: D-0472-2018
Classification: Class I
Recalling firm: International Laboratories, LLC
Product quantity: 218772 bottles
Termination date: May 7, 2020
Reason for recall: LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
Distribution pattern: Nationwide within the US
Recall initiation date: Jan 4, 2018
Initial firm notification: E-Mail
Center classification date: Feb 20, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0472-2018, published Feb 7, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

International Laboratories Clopidogrel Tablets Recall

Summary