Ingredient record · Cholesterol-lowering statin
Atorvastatin: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
7 entries containing Atorvastatin are on India's banned-drugs list, and 5 are banned today. 60 batches of medicines containing Atorvastatin failed a government lab test between March 2019 and September 2026, from 39 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
5
Banned combinations in force
2
Other listed orders (stayed, restricted, quashed)
60
Batches failed a lab test
Sep 2026
Latest lab alert
On the banned-drugs list
Atorvastatin on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Atorvastatin + Acetyl Salicylic Acid + CaffeineFixed-dose combination · painkillers | Banned | S.O. 184(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Atorvastatin + Omega 3 Fatty Acid 250mgFixed-dose combination · cardiac | Banned | S.O. 212(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Atorvastatin + UbidecarenoneFixed-dose combination · cardiac | Banned | S.O. 213(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Atorvastatin + Vitamin D3 + Folic Acid Vitamin B12 + PyridoxineFixed-dose combination · vitamins | Banned | S.O. 4452(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin + AtorvastatinFixed-dose combination · diabetes | Banned | S.O. 4453(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Atorvastatin + Vitamin D3 + Folic Acid + Vitamin B12 + PyridoxineFixed-dose combination · vitamins | Quashed | S.O. 784(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin + AtorvastatinFixed-dose combination · diabetes | Quashed | S.O. 785(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Atorvastatin | 32 | 16 | Sep 2026 |
| Atorvastatin Calcium | 8 | 5 | Jan 2026 |
| Atorvastatin Clopidogrel | 4 | 4 | Jul 2026 |
| Aspirin Gastro Resistant Atorvastatin | 3 | 2 | Aug 2026 |
| Atorvastatin Aspirin | 2 | 2 | Feb 2023 |
| Orvastin | 2 | 1 | Jul 2021 |
| Atorvastatin Aspirin Clopidogrel S | 1 | 1 | Feb 2026 |
| Supator | 1 | 1 | Nov 2025 |
| Aspirin Gastro Resistance Atorvastatin | 1 | 1 | Oct 2025 |
| Atorest | 1 | 1 | Oct 2025 |
| Apvaas | 1 | 1 | Jan 2023 |
| Atorvadoc | 1 | 1 | Dec 2022 |
| Statix | 1 | 1 | Jul 2021 |
| Atorfirst | 1 | 1 | May 2020 |
| Atormax | 1 | 1 | Mar 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Atorvastatin Tablets IP 40mg | Batch SBT-933Mfg Mar 2026 · Exp Feb 2028 | Sarthak Biotech Pvt. Ltd | The sample does not comply as per I.P. 2022 with respect to the test for "Dissolution" of Atorvasratin.Dissolution | RDTL, GuwahatiCDSCO lab | Sep 2026 |
| Atorvastatin Tablets IP 10mg | Batch AT26036Mfg Mar 2026 · Exp Aug 2027 | Eurokem Laboratories Pvt ltd | DissolutionDissolution | DTL, Chennai-06State lab | Aug 2026 |
| Aspirin Gastro-resistant and Atorvastatin Capsules IP (75 mg/10 mg) | Batch AAC5066Mfg Aug 2025 · Exp Jul 2027 | Vivimed Labs LimitedTelangana | Test for Dissolution of Aspirin and AtorvastatinDissolution | DTL, Bengaluru, KarnatakaState lab | Aug 2026 |
| Atorvastatin and Clopidogrel Tablets | Batch PGT25-3110AMfg Nov 2025 · Exp Oct 2027 | Plena RemediesHimachal Pradesh | Does not conform to required standards with respect to the test AssayAssay | Food & Drugs Laboratory Bambolim, GoaState lab | Jul 2026 |
| Atorvastatin Tablets IP 10mg | Batch AV26072Mfg Apr 2026 · Exp Sep 2027 | Eurokem Laboratories Pvt ltd | DissolutionDissolution | Drugs Testing Laboratory, Chennai-06State lab | Jul 2026 |
| Atorvastatin Tablets IP 20mg | Batch 0062Mfg Jul 2025 · Exp Jun 2027 | Hindustan Antibiotics LtdMaharashtra | The sample does not conform to claim as per IP 2022 in respect to test of Related substances.Related substances | RDTL, ChandigarhCDSCO lab | Jun 2026 |
| Atorvastatin Tablets IP 10mg | Batch AC25002Mfg May 2025 · Exp Apr 2027 | Eurokem Laboratories Pvt ltdTamil Nadu | The Sample does not meets the Specifications wrt. Dissolution Test as per IP.Dissolution | State Lab, DCL, TelanganaState lab | Jun 2026 |
| Atorvastatin Tablets IP 10mg | Batch AUVT1304Mfg Jul 2025 · Exp Jun 2027 | Unicure India LtdUttar Pradesh | Does not conform to IP Standards with respect to the Dissolution TestDissolution | Government Analyst, Food & Drugs Admn. Bambolim, GoaState lab | May 2026 |
| Atorvastatin Tablets IP 10mg | Batch RT - 250622Mfg Jun 2025 · Exp May 2027 | Relief Biotech Pvt. LtdDelhi | DissolutionDissolution | DTL, Chennai-06State lab | May 2026 |
| Atorvastatin Tablets IP 10mg | Batch ND251642Mfg Oct 2025 · Exp Sep 2027 | Nanoceut Therapeutics Pvt. LtdPuducherry | ContentOther | DTL, Madurai-19State lab | May 2026 |
| Aspirin Gastro-resistant and Atorvastatin Capsules IP (75mg/10mg) | Batch AAC5053Mfg Jul 2025 · Exp Jun 2027 | Vivimed Labs LimitedTelangana | The sample does not conforms to I.P.2022 with respect to the Test for Related substances for Aspirin and Atorvastatin.Related substances | CDTL, MumbaiCDSCO lab | May 2026 |
| Atorvastatin, Aspirin & Clopidogrel Capsules s | Batch ADH24148AMfg Oct 2024 · Exp Sep 2026 | Astonea Labs Pvt. LtdHaryana | Test free Salycylic AcidOther | MaharashtraState lab | Feb 2026 |
| Atorvastatin Tablets IP 10mg | Batch CT250131AMfg May 2025 · Exp Apr 2027 | Candour PharmaceuticalsHimachal Pradesh | DissolutionDissolution | DTL, Chennai-06State lab | Feb 2026 |
| Atorvastatin Calcium Tablets IP 10mg | Batch HTN792GMfg Jul 2024 · Exp Jun 2026 | Himalaya Meditek Pvt. LtdUttarakhand | DissolutionDissolution | Drugs Testing Laboratory, Chennai-06State lab | Jan 2026 |
| Atorvastatin Tablets IP 20mg | Batch CT24250048Mfg Apr 2024 · Exp Mar 2026 | CMG Biotech Pvt. Ltd | Assay and Dissolution testAssay | SDT&RL, BhubaneswarState lab | Dec 2025 |
Showing 15 of 60 records
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.