Ingredient record · Lowers blood fats (triglycerides)
Fenofibrate: 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
No combination containing Fenofibrate is on India's banned-drugs list. 8 batches of medicines containing Fenofibrate failed a government lab test between May 2021 and April 2026, from 8 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Fenofibrate 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.
No entry containing Fenofibrate is on the list compiled from CDSCO's Section 26A notifications (1983 to 2026). That is not a statement that every product containing it is safe.
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 |
|---|---|---|---|
| Fenofibrate | 4 | 4 | Feb 2026 |
| Rosuvastatin Fenofibrate | 1 | 1 | Apr 2026 |
| Indifiber | 1 | 1 | Jan 2023 |
| Fenosky | 1 | 1 | Dec 2022 |
| Rosuvas F | 1 | 1 | May 2021 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| 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 |
| Fenofibrate Capsules I.P (200 mg) | Batch FFC1201Mfg Jul 2024 · Exp Jun 2026 | Unicure India LtdUttar Pradesh | Test for Uniformity of Weight and DissolutionDissolution | DTL, Bengaluru, KarnatakaState lab | Feb 2026 |
| Fenofibrate Tablets I.P. 160 mg | Batch MT250955Mfg Mar 2025 · Exp Feb 2027 | Mascot Health Series Pvt. LtdUttarakhand | The sample does not comply as per I.P. 2022 with respect to the test for "Dissolution" of Fenofibrate.Dissolution | RDTL, GuwahatiCDSCO lab | Oct 2025 |
| Fenofibrate Capsules IP 200 mg (LIPICARD) | Batch 28022587Mfg Nov 2021 · Exp Oct 2023 | USV Private LimitedHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab | Nov 2023 |
| INDIFIBER (Fenofibrate Capsules I.P.) | Batch 6078Mfg Apr 2022 · Exp Mar 2024 | Ridley Life Science Pvt. LtdDelhi | DissolutionDissolution | CDTL MumbaiCDSCO lab | Jan 2023 |
| Fenosky - 200 (Fenofibrate Tablets I.P. 200 mg) | Batch T220209Mfg Feb 2022 · Exp Jan 2024 | Medisky Pharmaceuticals Pvt. LtdGujarat | DissolutionDissolution | CDL KolkataCDSCO lab | Dec 2022 |
| Fenofibrate Tablets I.P. 160 mg | Batch MG22007Mfg Apr 2022 · Exp Mar 2024 | Laboratories Griffon Pvt. LtdTamil Nadu | Uniformity of weightUniformity of weight/content | CDTL MumbaiCDSCO lab | Oct 2022 |
| Rosuvas� F-5 (Rosuvastatin and Fenofibrate Tablets I.P.) | Batch EMU2687Mfg Sep 2019 · Exp Feb 2022 | Sun Pharma Laboratories LtdSikkim | Dissolution of FenofibrateDissolution | CDL KolkataCDSCO lab | May 2021 |
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.