Clopidogrel Tablets — Class I drug recall D-0472-2018
Terminated recall by International Laboratories, LLC, reported 2018-02-07, distributed nationwide. LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, U
| Recall number | D-0472-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Laboratories, LLC, Seminole, FL, United States |
| Recall initiated | 2018-01-04 |
| Classified | 2018-02-20 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2020-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 218,772 bottles |
| Reason classes | labeling |
| NDC | 54458-0888-16 |
| Lot numbers | 08/19, 117099A |
Product
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
Reason for recall
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0472-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.