CLASS III Drug recall · Reported 27 Feb 2019 · FDA Enforcement Report
Lovastatin Tablets USP, 40 mg recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Lovastatin Tablets USP, 40 mg, distributed nationwide in the US. The recall was initiated on 13 Feb 2019 and the FDA has classified it as Class III.
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-0513-2019
- FDA event ID
- 82126
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Lovastatin
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Feb 2019
- FDA classified
- 20 Feb 2019
- Reported
- 27 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cholesterol Medication
Timeline
| 13 Feb 2019 | Recall initiated by company | |
| 20 Feb 2019 | Classified by FDA | +7 days |
| 27 Feb 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Which lots are affected?
Lot #: a) G702755, Exp March 2020; b) G702756, Exp March 2020
Where was it sold?
Nationwide in the USA 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Lupin Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalledGlucagon | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
Other Lovastatin recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lovastatin Tablets USP, 40 mg recalled by American Health PackagingLovastatin | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Lovastatin Tablets USP, 40 mg Unit Dose recalled by AVKARE | Avkare | Potency & Assay | Nationwide |
| Drug | CLASS II | Lovastatin, Tablet, 20 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |