Ingredient record · Cholesterol-lowering statin
Rosuvastatin: 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
2 entries containing Rosuvastatin are on India's banned-drugs list, and 0 are banned today. 21 batches of medicines containing Rosuvastatin failed a government lab test between April 2020 and May 2026, from 13 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
0
Banned combinations in force
2
Other listed orders (stayed, restricted, quashed)
21
Batches failed a lab test
May 2026
Latest lab alert
On the banned-drugs list
Rosuvastatin 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 |
|---|---|---|---|---|---|
| Rosuvastatin 20mg + Clopidogrel 75mg + Aspirin 150mg (Gastro-Resistant) CapsuleFixed-dose combination · cardiac | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 18 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Rosuvastatin 10mg + Clopidogrel 75mg + Aspirin 150mg (Gastro-Resistant) CapsuleFixed-dose combination · cardiac | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 19 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette 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 |
|---|---|---|---|
| Rosuvastatin | 7 | 6 | May 2026 |
| Rosuvastatin Aspirin Clopidogrel | 4 | 3 | May 2026 |
| Rosuvastatin Calcium | 2 | 1 | Sep 2022 |
| Rosuvas | 2 | 1 | May 2021 |
| Rosuvastatin Fenofibrate | 1 | 1 | Apr 2026 |
| Rosuvastatin Vitamin D | 1 | 1 | Jun 2023 |
| Loose Yellow Colored | 1 | 1 | Jan 2023 |
| Rosuvas F | 1 | 1 | May 2021 |
| Corsave | 1 | 1 | Mar 2021 |
| Rosloy Asp / | 1 | 1 | Nov 2020 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Rosuvastatin, Aspirin and Clopidogrel Capsules | SIBP25509Mfg 2025-08 · Exp 2027-07 | Bioaltus Pharmaceuticals Pvt. LtdSikkim | The sample does not conform to the claim with respect to Assay of Rosuvastatin and Aspirin.Assay | DTL JaipurState lab | May 2026 |
| Rosuvastatin Tablets IP 20 mg | RVST-1040Mfg 2025-11 · Exp 2027-10 | Wings Biotech LLPHimachal Pradesh | The sample does not conform to I.P with respect to the test for Related substancesRelated substances | CDL, KolkataCDSCO lab | May 2026 |
| Rosuvastatin with Fenofibrate Tablets | RDF-2504Mfg 2025-06 · Exp 2027-06 | Life Line Pharma 188/1Puducherry | MISBRANDED DRUG In the composition the label should be mentioned as Rosuvastatin and Fenofibrate tablets IP. But the label is mentioned as only Rosuvastatin and Fenofibrate tablets. Hence it is Misbranded drug as per section 17 of Drugs and Cosmetics Act 1940.Misbranded | State Lab, DCL, TelanganaState lab | Apr 2026 |
| Rosuvastatin 10 mg, Aspirin 150 mg and Clopidogrel 75 mg Capsules | SIBP24283Mfg 2024-06 · Exp 2026-05 | Bioaltus Pharmaceuticals Pvt. LtdSikkim | Assay for RosuvastatinAssay | DTL, Bengaluru, KarnatakaState lab | Oct 2025 |
| Rosuvastatin, Aspirin & Clopidogrel Capsules (20mg/75mg/75 mg) | MC240184Mfg 2024-02 · Exp 2026-01 | Mascot Health Series Pvt. LtdUttarakhand | Sample does not conform to Label claim with respect to the content of Aspirin and to Schedule V of Drugs and Cosmetics Act, with respect to free Salicylic Acid.Labelling | DTL ChennaiState lab | Dec 2024 |
| Rosuvastatin Tablets IP (Rosuvas 10) | SIE0116AMfg 2023-02 · Exp 2025-07 | Under Investigation | Dissolution and AssayAssay | Not applicableState lab | Oct 2024 |
| Rosuvastatin Tablets IP (ROZUTIN- 10) | VDT-23531Mfg 2023-06 · Exp 2025-05 | Vidhyasha PharmaceuticalsHimachal Pradesh | Related SubstancesRelated substances | CDL KolkataCDSCO lab | Oct 2024 |
| Rosuvastatin Tablets IP (Rosuvas 10 Tablets) | SID3056AMfg 2022-11 · Exp 2025-04 | Sun Pharma Laboratories Ltd | Description and Assay of Rosuvastatin Calcium calculated as RosuvastatinAssay | RDTL ChandigarhState lab | Jul 2023 |
| Rosuvastatin & Vitamin D3 Tablets | 22S1GTA576Mfg 2022-05 · Exp 2024-04 | Synokem Phramaceuticals LtdUttarakhand | Assay of RosuvastatinAssay | CDL KolkataCDSCO lab | Jun 2023 |
| Rosuvastatin, Aspirin and Clopidogrel Capsules | UGC22071Mfg 2022-03 · Exp 2024-02 | Unimarck Healthcare LtdUttarakhand | Description, Assay & Dissolution of RosuvastatinAssay | CDL KolkataCDSCO lab | Feb 2023 |
| Loose yellow colored Tablets (Purported to contain Rosuvastatin 10 mg) | Not applicableMfg ? · Exp ? | Trizal FormulationHimachal Pradesh | Assay of RosuvastatinAssay | RDTL ChandigarhState lab | Jan 2023 |
| Rosuvastatin Calcium Tablets IP 10 mg | 21S1GTA035Mfg 2021-01 · Exp 2022-12 | Synokem Pharmaceuticals LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiState lab | Sep 2022 |
| Rosuvastatin Calcium Tablets IP 10mg | 21S1GTA035Mfg 2021-01 · Exp 2022-12 | Synokem Pharmaceuticals LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiState lab | May 2022 |
| Rosuvas� F-5 (Rosuvastatin and Fenofibrate Tablets I.P.) | EMU2687Mfg 2019-09 · Exp 2022-02 | Sun Pharma Laboratories LtdSikkim | Dissolution of FenofibrateDissolution | CDL KolkataCDSCO lab | May 2021 |
| Rosuvas 20 (Rosuvastatin Tablets I.P.) | EMX0685Mfg 2020-03 · Exp 2023-08 | Sun Pharma Laboratories LtdSikkim | Dissolution & AssayAssay | CDL KolkataCDSCO lab | May 2021 |
Showing 15 of 21 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.