CLASS II Drug recall · Reported 29 Nov 2017 · FDA Enforcement Report
Pravastatin Sodium USP, tablets, 40 mg recalled by Lupin
Lupin is recalling Pravastatin Sodium USP, tablets, 40 mg, distributed nationwide in the US. The recall was initiated on 17 Nov 2017 and the FDA has classified it as Class II.
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-0092-2018
- FDA event ID
- 78566
- Recalling firm
- Lupin, Vasco Da Gama, N/A
- Brand
- Pravastatin Sodium
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Nov 2017
- FDA classified
- 21 Nov 2017
- Reported
- 29 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cholesterol Medication
Timeline
| 17 Nov 2017 | Recall initiated by company | |
| 21 Nov 2017 | Classified by FDA | +4 days |
| 29 Nov 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Product as listed by the FDA
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09
Where it was distributed
Product was distributed throughout the United States, including Puerto Rico.
Questions about this recall
Is Pravastatin Sodium USP, tablets, 40 mg recalled?
Yes. Lupin recalled Pravastatin Sodium USP, tablets, 40 mg on 17 Nov 2017. The recall is Class II and its status is Terminated. Recall number D-0092-2018.
Why was it recalled?
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Which lots are affected?
Lot # G702459, Exp 2/20
Where was it sold?
Product was distributed throughout the United States, including 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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 Lupin
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Escitalopram Tablets USP 20 mg recalled by LupinEscitalopram | Lupin | Other | Nationwide |
| Drug | CLASS III | Amlodipine Besylate Tablets USP, 10mg recalled by LupinAmlodipine Besylate | Lupin | Manufacturing (CGMP) Deviations | |
| Drug | CLASS III | Amlodipine Besylate Tablets USP, 5mg recalled by LupinAmlodipine Besylate | Lupin | Manufacturing (CGMP) Deviations |
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., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 20mg, a) recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, 20mg, a) recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP, 80mg, a) recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pravastatin Sodium Tablets, USP 80mg recalledPravastatin Sodium | Glenmark Pharmaceuticals Inc., U | Potency & Assay | Nationwide |