Ingredient record · Cholesterol-lowering statin
Rosuvastatin: 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
2 entries containing Rosuvastatin are on India's banned-drugs list, and 0 are banned today. 23 batches of medicines containing Rosuvastatin failed a government lab test between April 2020 and August 2026, from 15 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)
23
Batches failed a lab test
Aug 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 | 8 | 7 | Aug 2026 |
| Rosuvastatin Aspirin Clopidogrel | 5 | 4 | Aug 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, Clopidogrel & Aspirin Capsules | Batch LC26A044HMfg Jan 2026 · Exp Jun 2027 | Lifecare Neuro Products LimitedHimachal Pradesh | Free Salicylic AcidOther | DTL, Chennai-06State lab | Aug 2026 |
| Rosuvastatin Tablets IP 5mg | Batch IT04501Mfg Jul 2025 · Exp Jun 2025 | Inducare Pharmaceutical and Research FoundatiionMaharashtra | The sample does not comply with IP requirements for the dissolution test, The Sample is Declared As Misbranded Vide Rule 96 Section 17(b) and 127, of Drugs And Cosmetics Act, 1940 And Rules 1945, as the Manufacturer does not stated name of the Colour used, in the Composition of Sample, on the Sample blisters and carton and Mfg. Date is not mentioned on the Sample BlistersDissolution | FDAL, MumbaiState lab | Aug 2026 |
| Rosuvastatin, Aspirin and Clopidogrel Capsules | Batch SIBP25509Mfg Aug 2025 · Exp Jul 2027 | 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 | Batch RVST-1040Mfg Nov 2025 · Exp Oct 2027 | 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 | Batch RDF-2504Mfg Jun 2025 · Exp Jun 2027 | 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 | Batch SIBP24283Mfg Jun 2024 · Exp May 2026 | Bioaltus Pharmaceuticals Pvt. LtdSikkim | Assay for RosuvastatinAssay | DTL, Bengaluru, KarnatakaState lab | Oct 2025 |
| Rosuvastatin, Aspirin & Clopidogrel Capsules (20mg/75mg/75 mg) | Batch MC240184Mfg Feb 2024 · Exp Jan 2026 | 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) | Batch SIE0116AMfg Feb 2023 · Exp Jul 2025 | Under Investigation | Dissolution and AssayAssay | Not applicableState lab | Oct 2024 |
| Rosuvastatin Tablets IP (ROZUTIN- 10) | Batch VDT-23531Mfg Jun 2023 · Exp May 2025 | Vidhyasha PharmaceuticalsHimachal Pradesh | Related SubstancesRelated substances | CDL KolkataCDSCO lab | Oct 2024 |
| Rosuvastatin Tablets IP (Rosuvas 10 Tablets) | Batch SID3056AMfg Nov 2022 · Exp Apr 2025 | Sun Pharma Laboratories Ltd | Description and Assay of Rosuvastatin Calcium calculated as RosuvastatinAssay | RDTL ChandigarhState lab | Jul 2023 |
| Rosuvastatin & Vitamin D3 Tablets | Batch 22S1GTA576Mfg May 2022 · Exp Apr 2024 | Synokem Phramaceuticals LtdUttarakhand | Assay of RosuvastatinAssay | CDL KolkataCDSCO lab | Jun 2023 |
| Rosuvastatin, Aspirin and Clopidogrel Capsules | Batch UGC22071Mfg Mar 2022 · Exp Feb 2024 | Unimarck Healthcare LtdUttarakhand | Description, Assay & Dissolution of RosuvastatinAssay | CDL KolkataCDSCO lab | Feb 2023 |
| Loose yellow colored Tablets (Purported to contain Rosuvastatin 10 mg) | Batch Not applicableMfg ? · Exp ? | Trizal FormulationHimachal Pradesh | Assay of RosuvastatinAssay | RDTL ChandigarhState lab | Jan 2023 |
| Rosuvastatin Calcium Tablets IP 10 mg | Batch 21S1GTA035Mfg Jan 2021 · Exp Dec 2022 | Synokem Pharmaceuticals LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiState lab | Sep 2022 |
| Rosuvastatin Calcium Tablets IP 10mg | Batch 21S1GTA035Mfg Jan 2021 · Exp Dec 2022 | Synokem Pharmaceuticals LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiState lab | May 2022 |
Showing 15 of 23 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.