International Laboratories Pravastatin Tablets Recalled Due to Label Mix-Up
International Laboratories recalls Pravast: 40mg tablets labeled as Pravastatin but contain Bupropion hydrochloride. This mix-up poses a risk of incorrect medication use. Consumers should check product labels and contact the company for details.
Recall notice
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Contact the company
What happened, in plain English
International Laboratories is recalling Pravastatin Sodium Tablets that were mislabeled with Bupropion hydrochloride. This mix-up could lead to taking the wrong medication, which may cause serious health issues. Read more at govinfonow.com/recall/41408-international-laboratories-pravastatin-tablets-recalled-due-to-label-mix-up.
Source Summary by GovInfoNow · govinfonow.com/recall/41408-international-laboratories-pravastatin-tablets-recalled-due-to-label-mix-up · Updated October 7, 2026 · FDA enforcement record: FDA #D-0102-2018
Cite this page
“International Laboratories Pravastatin Tablets Recalled Due to Label Mix-Up.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41408-international-laboratories-pravastatin-tablets-recalled-due-to-label-mix-up. Based on FDA recall #D-0102-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0102-2018%22&limit=1).
Why it’s dangerous
The tablets were mislabeled, meaning they contain Bupropion hydrochloride instead of Pravastatin sodium. Bupropion is a different medication used for depression, which can cause serious side effects if taken incorrectly.
Who’s affected
People who have the 40mg Pravastatin tablets labeled as Pravastatin but contain Bupropion hydrochloride are affected. Those with prescription medication for high cholesterol or depression may be at higher risk.
How to tell if you have this one
Check for the product labeled as Pravastatin sodium tablets 40mg with the NDC code 54458-925-16. The lot number is 115698A and expiration date is February 2019.
- Brand
International Laboratories- Category
Drug
What to do — step by step
Check Product Label
Look for the label that says 'Pravastatin sodium tablets 40 mg' but contains Bupropion hydrochloride instead.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S.A. nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0102-2018 (August 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0102-2018 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.