International Laboratories Pravastatin Sodium Tablets Recall

Why it was recalled

Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.

Product description

Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16

Lot numbers, UPCs & expiration codes

Lot # 115698A, Exp 02/19

Where it was sold

U.S.A. nationwide and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0102-2018
Classification: Class I
Status: Terminated
Recall initiated: Aug 7, 2017
FDA report date: Dec 13, 2017
Quantity: 82056 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: International Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0102-2018, exactly as published.

Show all FDA fields

City: St Petersburg
State: FL
Status: Terminated
Country: United States
Event ID: 77899
Address: 2701 75th St N
Code information: Lot # 115698A, Exp 02/19
Postal code: 33710-2938
Report date: Dec 13, 2017
Product type: Drugs
Recall number: D-0102-2018
Classification: Class I
Recalling firm: International Laboratories, Inc.
Product quantity: 82056 bottles
Termination date: May 2, 2019
Reason for recall: Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
Distribution pattern: U.S.A. nationwide and Puerto Rico
Recall initiation date: Aug 7, 2017
Initial firm notification: Letter
Center classification date: Dec 1, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0102-2018, published Dec 13, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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