HMG-CoA Reductase Inhibitor
Where is Lovastatin made?
6 companies sell it under their own name and 24 repackagers rebottle it. Their labels name 3 factories in India, the United States and Croatia.
India 1United States 1Croatia 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| International Laboratories, LLC10 mg, 20 mg, 40 mg · NDC 54458-938, 54458-846, 54458-937 +5 | Lupin LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Pliva Hrvatska d.o.o.Makes it | Zagreb, Croatia | Problems found, fixed voluntarilyOct 2023 | |
| BluePoint Laboratories.10 mg, 20 mg, 40 mg · NDC 68001-314, 68001-315, 68001-316 | Lupin LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Carlsbad Technology, Inc.10 mg, 20 mg, 40 mg · NDC 61442-141, 61442-142, 61442-143 | Carlsbad Technology, Inc.Makes it | Carlsbad, CA, United States | Problems found, fixed voluntarilyJun 2026 |
| Lupin Pharmaceuticals, Inc.10 mg, 20 mg, 40 mg · NDC 68180-467, 68180-468, 68180-469 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Mutual Pharmaceutical Company, Inc.10 mg, 20 mg, 40 mg · NDC 53489-607, 53489-608, 53489-609 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.10 mg, 20 mg, 40 mg · NDC 0093-0926, 0093-0576, 0093-0928 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Lovastatin in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-3268,50090-3396,50090-3881,50090-0759+3 - Aidarex Pharmaceuticals LLC:
33261-547,53217-304,33261-548,33261-549 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-763,71610-396,71610-709,71610-775 - Blenheim Pharmacal, Inc.:
10544-235,10544-241,10544-246,10544-242 - Boswell Pharmacy Services LLC d/b/a BPS Wholesale:
83209-468,83209-143 - Bryant Ranch Prepack:
63629-1178,63629-1191,63629-1018,72162-1739+5 - Coupler Enterprises Inc.:
67046-450,67046-451 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-755 - Direct Rx:
61919-311,61919-676,61919-547,61919-941 - Dispensing Solutions Inc.:
66336-602 - Golden State Medical Supply, Inc.:
51407-251,51407-252,51407-253 - Legacy Pharmaceutical Packaging:
68645-566,68645-567 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8151,0615-8152 - Northwind Pharmaceuticals:
51655-686,51655-873,51655-558,51655-469 - NuCare Pharmaceuticals.Inc.:
68071-3622,68071-4955,66267-506,68071-3615+4 - PD-Rx Pharmaceuticals, Inc.:
43063-493,55289-881,43063-692,43063-983+3 - Physicians Total Care, Inc.:
54868-4593,54868-4585,54868-4774 - Preferred Pharmaceuticals, Inc..:
68788-9180,68788-7056,68788-9181,68788-8326+4 - Proficient Rx LP:
63187-814,63187-194,71205-992,71205-440+6 - RPK Pharmaceuticals, Inc.:
53002-1385,53002-2385,53002-5701,53002-5700 - Rebel Distributors Corp..:
21695-534,42254-106,21695-535,42254-028+2 - Remedyrepack Inc.:
70518-2009,70518-0706,70518-3064,70518-2425 - Stat Rx USA:
16590-311 - Unit Dose Services:
50436-6601
Recalls
- Feb 19, 2019 · Class III · American Health Packaging
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. - Feb 13, 2019 · Class III · Lupin Pharmaceuticals Inc.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.