Pravastatin Sodium Tablets — Class I drug recall D-0102-2018
Terminated recall by International Laboratories, Inc., reported 2017-12-13, distributed nationwide. Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydr
| Recall number | D-0102-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Laboratories, Inc., St Petersburg, FL, United States |
| Recall initiated | 2017-08-07 |
| Classified | 2017-12-01 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2019-05-02 |
| Distributed | Nationwide (US) |
| Quantity | 82,056 bottles |
| Reason classes | labeling |
| NDC | 54458-0925-16 |
| Lot numbers | 02/19, 115698A |
Product
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
Reason for recall
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 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-0102-2018. 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.