CLASS I Drug recall · Reported 7 Feb 2018 · FDA Enforcement Report
Clopidogrel Tablets, USP 75 mg recalled by International Laboratories
International Laboratories is recalling Clopidogrel Tablets, USP 75 mg, distributed nationwide in the US. The recall was initiated on 4 Jan 2018 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0472-2018
- FDA event ID
- 78913
- Recalling firm
- International Laboratories, Seminole, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Jan 2018
- FDA classified
- 20 Feb 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Blood Thinners
Timeline
| 4 Jan 2018 | Recall initiated by company | |
| 7 Feb 2018 | Published in enforcement report | +34 days |
| 20 Feb 2018 | Classified by FDA | +13 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
Where it was distributed
Nationwide within the US
Questions about this recall
Why was it recalled?
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Which lots are affected?
Lot #: 117099A, Exp. 08/19
Where was it sold?
Nationwide within the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from International Laboratories
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 20 mg recalled | International Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 10 mg recalled | International Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS I | Pravastatin Sodium Tablets, USP, 40 mg recalled | International Laboratories | Packaging Defects | Nationwide |
Other Clopidogrel recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clopidogrel Tablets USP, 75 mg recalled by Preferred Pharmaceuticals | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clopidogrel Tablets USP, 75 mg recalled by Accord Healthcare | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Clopidogrel Tablets, USP, 75 mg recalled by Macleods Pharma UsaClopidogrel | Macleods Pharma Usa | Foreign Material | Nationwide |