Lupin Recalls Lovastatin Tablets Due to CGMP Deviations
Lupin Pharmaceuticals is recalling Lovastatin 40 mg tablets because the drug substance used was out of specification for impurity results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the violation is not likely to cause adverse health consequences. The hazard involves out-of-specification impurities without reported injuries, fitting the Moderate category for low-risk contamination or voluntary precautionary measures.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling 44,640 bottles of Lovastatin Tablets USP, 40 mg. The affected products are packaged in 60-count and 100-count bottles and are prescription-only. The recall covers specific lots with expiration dates in March 2020.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the finished product was manufactured using lovastatin drug substance that was out of specification for individual impurity results.
The affected products were distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should stop using the recalled medication and contact their pharmacist or healthcare provider for guidance on replacement or further instructions.
The recalled product
- Product
- LOVASTATIN (LOVASTATIN)
- Brand
- LOVASTATIN
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 44,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: a) G702755
- Exp March 2020
- b) G702756
UPCs (5)
- 0368180469070
- 0368180467076
- 0368180468073
- 0368180467038
- 0368180469032
Distribution
Related recalls
Same brand · LOVASTATIN
- ModerateAmerican Health Packaging Recalls Lovastatin Tablets Due to CGMP Deviations
FDA (Drugs) · 2019-08-14
Same manufacturer · Lupin Pharmaceuticals Inc.
See all →- ModerateLupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
- SevereGlucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- ModerateGanirelix acetate injection recalled after failing an impurity specification
FDA (Drugs) · 2025-12-17
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17