Ingredient record · Cholesterol-lowering statin
Atorvastatin: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
7 entries containing Atorvastatin are on India's banned-drugs list, and 5 are banned today. 57 batches of medicines containing Atorvastatin failed a government lab test between March 2019 and July 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)
57
Batches failed a lab test
Jul 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 | 30 | 16 | Jul 2026 |
| Atorvastatin Calcium | 8 | 5 | Jan 2026 |
| Atorvastatin Clopidogrel | 4 | 4 | Jul 2026 |
| Aspirin Gastro Resistant Atorvastatin | 2 | 2 | May 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 and Clopidogrel Tablets | PGT25-3110AMfg 2025-11 · Exp 2027-10 | 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 | AV26072Mfg 2026-04 · Exp 2027-09 | Eurokem Laboratories Pvt ltd | DissolutionDissolution | Drugs Testing Laboratory, Chennai-06State lab | Jul 2026 |
| Atorvastatin Tablets IP 20mg | 0062Mfg 2025-07 · Exp 2027-06 | 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 | AC25002Mfg 2025-05 · Exp 2027-04 | 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 | AUVT1304Mfg 2025-07 · Exp 2027-06 | 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 | RT - 250622Mfg 2025-06 · Exp 2027-05 | Relief Biotech Pvt. LtdDelhi | DissolutionDissolution | DTL, Chennai-06State lab | May 2026 |
| Atorvastatin Tablets IP 10mg | ND251642Mfg 2025-10 · Exp 2027-09 | Nanoceut Therapeutics Pvt. LtdPuducherry | ContentOther | DTL, Madurai-19State lab | May 2026 |
| Aspirin Gastro-resistant and Atorvastatin Capsules IP (75mg/10mg) | AAC5053Mfg 2025-07 · Exp 2027-06 | 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 | ADH24148AMfg 2024-10 · Exp 2026-09 | Astonea Labs Pvt. LtdHaryana | Test free Salycylic AcidOther | MaharashtraState lab | Feb 2026 |
| Atorvastatin Tablets IP 10mg | CT250131AMfg 2025-05 · Exp 2027-04 | Candour PharmaceuticalsHimachal Pradesh | DissolutionDissolution | DTL, Chennai-06State lab | Feb 2026 |
| Atorvastatin Calcium Tablets IP 10mg | HTN792GMfg 2024-07 · Exp 2026-06 | Himalaya Meditek Pvt. LtdUttarakhand | DissolutionDissolution | Drugs Testing Laboratory, Chennai-06State lab | Jan 2026 |
| Atorvastatin Tablets IP 20mg | CT24250048Mfg 2024-04 · Exp 2026-03 | CMG Biotech Pvt. Ltd | Assay and Dissolution testAssay | SDT&RL, BhubaneswarState lab | Dec 2025 |
| Atorvastatin Tablets IP 10mg (Atorwal-10) | IC434002Mfg 2024-02 · Exp 2026-01 | Innova Captab Ltd. 81-B EPIPHimachal Pradesh | Assay & Dissolution testAssay | SDT&RL, BhubaneswarState lab | Dec 2025 |
| Tablets of Supator-20 (AtorvastatinTablets IP 20mg) | SRTB240152Mfg 2024-02 · Exp 2026-01 | Systole Remedies Pvt. LtdHimachal Pradesh | Content of AtorvastatinOther | SDT&RL, BhubaneswarState lab | Nov 2025 |
| Atorvastatin and Clopidogrel Capsules | K2501777Mfg 2025-07 · Exp 2027-06 | Intas Pharmaceuticals Ltd BagheykholaSikkim | The sample does not conform to claim with respect to Assay of Atorvastatin.Assay | CDL, KolkataCDSCO lab | Nov 2025 |
Showing 15 of 57 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.