CLASS I Drug recall · Reported 13 Dec 2017 · FDA Enforcement Report
Pravastatin Sodium Tablets, USP, 40 mg recalled
International Laboratories is recalling Pravastatin Sodium Tablets, USP, 40 mg, distributed nationwide in the US. The recall was initiated on 7 Aug 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0102-2018
- FDA event ID
- 77899
- Recalling firm
- International Laboratories, St Petersburg, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 7 Aug 2017
- FDA classified
- 1 Dec 2017
- Reported
- 13 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Cholesterol Medication
Timeline
| 7 Aug 2017 | Recall initiated by company | |
| 1 Dec 2017 | Classified by FDA | +116 days |
| 13 Dec 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
Where it was distributed
U.S.A. nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Which lots are affected?
Lot # 115698A, Exp 02/19
Where was it sold?
U.S.A. nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from International Laboratories
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Clopidogrel Tablets, USP 75 mg recalled by International Laboratories | International Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 20 mg recalled | International Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 10 mg recalled | International Laboratories | Packaging Defects | Nationwide |
Other Pravastatin recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pravastatin Sodium Tablets 80mg recalled by Glenmark PharmaceuticalsPravastatin Sodium | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 20mg, a) recalled | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, 20mg, a) recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 80mg, a) recalled | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP 80mg recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |