Pravastatin Sodium Tablets — Class II drug recall D-0234-2018
Terminated recall by International Laboratories, Inc., reported 2018-01-31, distributed nationwide. Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in
| Recall number | D-0234-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Laboratories, Inc., Seminole, FL, United States |
| Recall initiated | 2018-01-12 |
| Classified | 2018-01-24 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2019-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 13,403 cartons |
| NDC | 54458-0926-16 |
| Lot numbers | 03/19, 117103A |
Product
Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser carton, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16.
Reason for recall
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
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-0234-2018. 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.