Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Pravastatin Sodium Tablets Recalled by International Laboratories, Inc. Due to Labeling: Label mix-up, the product labeled as Pravastatin...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact International Laboratories, Inc. directly.
Affected Products
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
Quantity: 82056 bottles
Why Was This Recalled?
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About International Laboratories, Inc.
International Laboratories, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report