International Laboratories, Inc. recalls Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing
International Laboratories recalls 10mg pravastatin tablets that may contain 20mg tablets. Consumers should check bottles for mixed tablet sizes to avoid incorrect dosing.
Lower-risk recall
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Contact the company & request your remedy
What happened, in plain English
International Laboratories is recalling 10mg pravastatin sodium tablets that could contain 20mg tablets in the same bottle. This risk of incorrect dosing could lead to unsafe medication levels. Read more at govinfonow.com/recall/40933-international-laboratories-recalls-pravastatin-10mg-tablets-due-to-foreign-tablets.
Source Summary by GovInfoNow · govinfonow.com/recall/40933-international-laboratories-recalls-pravastatin-10mg-tablets-due-to-foreign-tablets · Updated October 7, 2026 · FDA enforcement record: FDA #D-0233-2018
Cite this page
“International Laboratories recalls Pravastatin 10mg tablets due to foreign tablets in bottles.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40933-international-laboratories-recalls-pravastatin-10mg-tablets-due-to-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 bottles may contain both 10mg and 20mg tablets, leading to incorrect dosing. Taking more than prescribed could cause unsafe medication levels, but the risk is low as the tablets are for individual patient dispensing.
Who’s affected
People who have received the recalled 10mg pravastatin tablets from pharmacies. Those taking the medication for cholesterol management are most at risk if they accidentally take more than prescribed.
How to tell if you have this one
Check the bottle for 10mg pravastatin tablets labeled with a 10mg dose. The product was packaged in 12 x 30 tablets for individual patient dispensing, with NDC 54458-927-16.
- 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 Tablet Sizes
Inspect the bottle to see if it contains both 10mg and 20mg tablets.
Questions people ask
Is this product safe to use?
The product may contain foreign tablets, so it's not safe to use without checking the tablet sizes.
How can I tell if I have the recalled product?
Check the bottle for 10mg pravastatin tablets with NDC 54458-927-16, packaged in 12 x 30 tablets for individual patient dispensing.
What should I do if I have the recalled product?
Inspect the bottle for mixed tablet sizes; if you find both 10mg and 20mg tablets, stop using it and contact your pharmacist.
Contact International Laboratories
We’ve drafted a message you can send International Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0233-2018 — International Laboratories International Laboratories Hello, I own a International Laboratories that is covered by recall D-0233-2018 from International Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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 qwen3:4b on October 7, 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.