Recall: International Laboratories Pravastatin 10mg Foreign Tablets
International Laboratories recalls Pravastatin Sodium 10mg tablets due to potential foreign 20mg tablets. Check lot 117093A.
Use caution until it’s fixed
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Contact the company
What happened, in plain English
International Laboratories, Inc. is recalling Pravastatin Sodium Tablets, USP, 10 mg in 30-count bottles because the bottles may contain both 10 mg and 20 mg tablets. This mix-up poses a risk of incorrect dosing for patients taking this prescription medication. The affected product was distributed nationwide in the USA. Read more at govinfonow.com/recall/40933-recall-international-laboratories-pravastatin-10mg-foreign-tablets.
Source Summary by GovInfoNow · govinfonow.com/recall/40933-recall-international-laboratories-pravastatin-10mg-foreign-tablets · Updated October 11, 2026 · FDA enforcement record: FDA #D-0233-2018
Cite this page
“Recall: International Laboratories Pravastatin 10mg Foreign Tablets.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40933-recall-international-laboratories-pravastatin-10mg-foreign-tablets. Based on FDA recall #D-0233-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0233-2018%22&limit=1).
Why it’s dangerous
The hazard involves the presence of foreign tablets or capsules within the bottle. Specifically, a bottle intended to contain only 10 mg tablets may also contain 20 mg tablets, leading to potential accidental overdose or underdose if not identified.
Who’s affected
Patients who have been prescribed Pravastatin Sodium Tablets, USP, 10 mg by their healthcare provider are likely to be affected. Individuals who purchased these specific bottles from pharmacies across the United States are at risk of receiving incorrect dosages.
How to tell if you have this one
Check your medication bottles for the brand 'International Laboratories' and the specific NDC number 54458-927-16. Verify that the lot number is 117093A and the expiration date is 06/19. The product consists of Pravastatin Sodium Tablets, USP, 10 mg in 30-count bottles.
- Brand
International Laboratories- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0233-2018 | Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16.; Lot: 117093A, Exp. 06/19 | 9,052 cartons |
| D-0234-2018 | 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.; Lot: 117103A, Exp. 03/19 | 13,403 cartons |
What to do — step by step
Check Your Medication
Inspect your Pravastatin Sodium Tablets for lot number 117093A and expiration date 06/19.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacy or healthcare provider immediately for instructions on replacement or return.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0233-2018 (January 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0233-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.