Ingredient record · Antifungal
Fluconazole: 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
5 entries containing Fluconazole are on India's banned-drugs list, and 2 are banned today. 10 batches of medicines containing Fluconazole failed a government lab test between May 2019 and May 2025, from 10 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
2
Banned combinations in force
3
Other listed orders (stayed, restricted, quashed)
10
Batches failed a lab test
May 2025
Latest lab alert
On the banned-drugs list
Fluconazole itself appears on the list as a single drug, see the entries marked "Single molecule" below. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Ornidazole + Fluconazole + AzithromycinFixed-dose combination · antibiotics | Banned | S.O. 246(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. |
| Combikit of Azithromycin Dihydrate, Secnidazole and FluconazoleSingle molecule · antibiotics | Quashed | S.O. 4429(E) | 7 September 2018 | 328 FDCs · Sep 2018 | Quashed by Delhi HC order dated 18.02.2019; CDSCO appealed, sub judice (CDSCO list as on 22.11.2021, note 5#). |
| Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole TabletsSingle molecule · antibiotics | Banned | S.O. 4438(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Combikit of Azithromycin Dihydrate, Secnidazole and FluconazoleSingle molecule · antibiotics | Quashed | S.O. 760(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole TabletsSingle molecule · antibiotics | Quashed | S.O. 769(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 |
|---|---|---|---|
| Fluconazole | 7 | 7 | May 2025 |
| Fluconazole Pratiflu | 1 | 1 | May 2025 |
| Fluconazole Megmazole | 1 | 1 | Apr 2025 |
| Fluconazole Flucol | 1 | 1 | Dec 2020 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Fluconazole IP Powder | FLZ23-2411Mfg 2023-11 · Exp 2028-10 | Mestra Pharma Pvt. LtdUttarakhand | Loss on drying: Does not comply with IPLoss on drying | State Food & Drug Testing Laboratory UttarakhandState lab | May 2025 |
| Fluconazole 150mg Tablets IP (PRATIFLU 150 Tablets | PPTS-2801Mfg 2024-08 · Exp 2027-07 | Pratima PharmaceuticalsMaharashtra | The content of Fluconazole in the sample is less (i.e 31.96% of the stated amount) (I.P. Limits:- Not less than 90% and not more than 110% of the stated Amount)Other | V.P. Khedkar, Pune-Zone 2State lab | May 2025 |
| Fluconazole Tablets I.P. 150 mg (Megmazole- 150 Tablets) | TSF-C0116Mfg 2024-01 · Exp 2025-12 | Spen Formulations Pvt. Ltd | Assay/Content of FluconazoleAssay | RDTL GuwahatiCDSCO lab | Apr 2025 |
| Fluconazole Tablets IP 150 mg (Flucse - 150) | CHT23621Mfg 2024-02 · Exp 2026-01 | Cureza Healthcare Pvt. Ltd | Uniformity of weightUniformity of weight/content | CDTL MumbaiCDSCO lab | Sep 2024 |
| Fluconazole Tablets IP (150 mg).. | UGT233 38Mfg 2023-03 · Exp 2025-02 | Unimark Healthcare LtdUttarakhand | The sample received does not conform to the I.P.2022 standard with respect to the test for Related substances.Related substances | CDTL MumbaiCDSCO lab | May 2024 |
| Fluconazole Tablets IP (Aclohix-400 Tablets) | MAY 23142Mfg 2023-05 · Exp 2025-04 | Bonsai PharmaHimachal Pradesh | DissolutionDissolution | RDTL ChandigarhState lab | Oct 2023 |
| Fluconazole Capsules I.P. 150 mg | 4700821Mfg 2021-11 · Exp 2023-10 | Karnataka Antibiotics & Pharmaceuticals LtdKarnataka | Uniformity of weightUniformity of weight/content | CDTL MumbaiCDSCO lab | May 2022 |
| Fluconazole Tablets IP 150 mg FLUCOL TABLETS | BY20002Mfg 2020-03 · Exp 2022-02 | Ortin Laboratories LtdTelangana | Dissolution and Related SubstancesDissolution | RDTL ChandigarhCDSCO lab | Dec 2020 |
| Fluconazole Tablets | TOH-02Mfg 2019-04 · Exp 2021-03 | Om Biomedic Pvt. LtdUttarakhand | Uniformity of DispersionUniformity of weight/content | CDL KolkataCDSCO lab | Jan 2020 |
| Fluconazole Tablets IP (FLUTIS-150 TABLETS) | SDS874Mfg 2018-05 · Exp 2020-04 | Scott-Edil Pharmacia LtdHimachal Pradesh | DissolutionDissolution | RDTL ChandigarhCDSCO lab | May 2019 |
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.