Ingredient record · Antifungal, often in creams and shampoos
Ketoconazole: 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
11 entries containing Ketoconazole are on India's banned-drugs list, and 6 are banned today. 22 batches of medicines containing Ketoconazole failed a government lab test between April 2019 and September 2026, from 18 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
6
Banned combinations in force
5
Other listed orders (stayed, restricted, quashed)
22
Batches failed a lab test
Sep 2026
Latest lab alert
On the banned-drugs list
Ketoconazole 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 |
|---|---|---|---|---|---|
| Ketoconazole 2.0% w/w + Neomycin Sulphate 0.5% w/w + Iodochlorhydroxyquinoline 1% w/w + Tolnaftate 1% w/w + Clobetasol Propionate 0.05% w/w CreamFixed-dose combination · skin | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 6 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Ketoconazole 2.0% w/w + Iodochlorhydroxyquinoline 1% w/w + Tolnaftate 1% w/w + Clobetasol Propionate 0.05% w/w + Neomycin Sulphate 0.10% w/w CreamFixed-dose combination · skin | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 34 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Ketoconazole + Zinc Pyrithione + D-Panthenol + Tea Tree Oil + AloesFixed-dose combination · skin | Banned | S.O. 3318(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ketoconazole + Aloe Vera + Vitamin a AcetateFixed-dose combination · skin | Banned | S.O. 3319(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ketoconazole + Aloes + ZPTOFixed-dose combination · skin | Banned | S.O. 3320(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Clobetasol + Ofloxacin + Ketoconazole + Zinc SulphateFixed-dose combination · skin | Banned | S.O. 4664(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Gentamicin + Tolnaftate + Iodochlorhydroxyquinoline + KetoconazoleFixed-dose combination · skin | Banned | S.O. 4666(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ketoconazole + Tea Tree Oil + Allantoin + Inc Oxide + Aloe Vera + Jojoba Oil + Lavender Oil + Soap NoodlesFixed-dose combination · skin | Banned | S.O. 4671(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Ofloxacin + Ketoconazole + Zinc SulphateFixed-dose combination · skin | Quashed | S.O. 1010(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clobetasol + Gentamicin + Tolnaftate + Iodochlorhydroxyquinoline + KetoconazoleFixed-dose combination · skin | Quashed | S.O. 1012(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ketoconazole + Tea Tree Oil + Allantion + Zincoxide + Aloevera + Jojobaoil + Lavanderoil + Soa P NoodlesFixed-dose combination · skin | Quashed | S.O. 1017(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 |
|---|---|---|---|
| Ketoconazole Medicated Soap | 4 | 3 | Sep 2026 |
| Ketoconazole | 4 | 4 | Apr 2026 |
| Ketoconazole Lodochlorhydroxyquinoline Neomycin Tolnaftate Clobetasol Propionate D Panthenol | 1 | 1 | Sep 2026 |
| Ketoconazole W/w | 1 | 1 | Sep 2026 |
| Ketoconazole Zinc Pyrithione Glycerine Soap | 1 | 1 | Sep 2026 |
| Ketoconazole Chloridexidine Glueconate Cetrinide Shampoo | 1 | 1 | Jul 2026 |
| Ketoconazole Chlorhexidine Gluconate | 1 | 1 | Jun 2026 |
| Ketoconazole Cetrimide Soap | 1 | 1 | May 2026 |
| Ketoconazole Soap W/w | 1 | 1 | Mar 2026 |
| Ketoconazole Iodochlorhydroxyquinoline Tolnaftate Neomycin Sulphate Clobetasol Propionate | 1 | 1 | Feb 2026 |
| Ketoconazole Soap | 1 | 1 | Feb 2026 |
| Ketoconazole Zinc Pyrithione Shampoo | 1 | 1 | Jun 2025 |
| Kelan Soap | 1 | 1 | Apr 2025 |
| Dermotil K Spray Ketoconazole Chlorhexidinegluc Onate | 1 | 1 | Nov 2024 |
| Ketoconazole Shampoo | 1 | 1 | Apr 2020 |
| Ocona Ct Scalp | 1 | 1 | Apr 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Ketoconazole, lodochlorhydroxyquinoline, Neomycin, Tolnaftate, Clobetasol Propionate and D Panthenol Cream | Batch 6093Mfg May 2026 · Exp Apr 2028 | Samson Laboratories Pvt. LtdHimachal Pradesh | The sample does not conform to declared formula in respect of content of Clobetasole PropionateOther | Gorakhpur, Uttar PradeshState lab | Sep 2026 |
| Ketoconazole, Zinc Pyrithione & Glycerine Soap | Batch 25120324Mfg Dec 2025 · Exp Nov 2027 | Astonea Labs Pvt. LtdHaryana | The sample does not conform to declared formula, in respect of content of Ketoconazole and Zinc Pyrithione.Other | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Ketoconazole medicated soap | Batch 9411Mfg Nov 2025 · Exp Oct 2027 | Vimson DermaGujarat | content - KetoconazoleOther | Drug Testing Laboratory, Madurai-19State lab | Sep 2026 |
| Ketoconazole cream 2% w/w | Batch 6P36Mfg Apr 2026 · Exp Mar 2028 | Yacca Lifesciences Pvt LtdUttarakhand | content- KetoconazoleOther | Drug Testing Laboratory, Chennai-6State lab | Sep 2026 |
| Ketoconazole 1% Medicated Soap | Batch JSM25-0276Mfg Aug 2025 · Exp Jul 2027 | Jaisanshu Medicare Pvt. LtdUttarakhand | AssayAssay | RDTL, Hubli, KarnatakaState lab | Aug 2026 |
| ketoconazole, Chloridexidine Glueconate & Cetrinide Shampoo | Batch L047D25Mfg Apr 2025 · Exp Mar 2027 | Disinfecto Chemical Industrial Pvt. Ltd. D-7Uttar Pradesh | Assay for chlorhexidine Gluconate onlyAssay | RDTL. Bellary KarnatakaState lab | Jul 2026 |
| Ketoconazole & Chlorhexidine Gluconate Lotion | Batch 129Mfg Sep 2025 · Exp Feb 2027 | Argion Cosmed India Pvt. LtdTamil Nadu | ContentOther | DTL, Chennai-06State lab | Jun 2026 |
| Ketoconazole & Cetrimide Soap | Batch CX-041Mfg Nov 2025 · Exp Oct 2027 | SMB Healthcare | ContentOther | DTL, Chennai-06State lab | May 2026 |
| Ketoconazole Tablets IP 200 mg | Batch AD00112001Mfg Jan 2025 · Exp Dec 2026 | Admed Pharma Pvt. LtdHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Ketoconazole Soap 2% w/w) | Batch ADE25561Mfg May 2025 · Exp Apr 2027 | Astonea Labs Pvt. LtdHaryana | Assay ketoconazoleAssay | RDTL, Bellary, KarnatakaState lab | Mar 2026 |
| Ketoconazole Medicated Soap 75 g | Batch 9221Mfg Oct 2025 · Exp Sep 2027 | Vimson DermaGujarat | ContentOther | DTL,ChennaiState lab | Mar 2026 |
| Ketoconazole, Iodochlorhydroxyquinoline, tolnaftate, Neomycin Sulphate & Clobetasol Propionate | Batch GE25077Mfg Jun 2025 · Exp May 2027 | Lifecom Pharmaceuticals (India) Pvt.LtdUttarakhand | Assay of clobetasol Propionate IP & Ketoconazole IPAssay | FDTL,UttarakhandState lab | Feb 2026 |
| Ketoconazole Soap | Batch KEZ-017Mfg Aug 2025 · Exp Jul 2027 | SMB Healthcare | ContentOther | DTL, Chennai-06State lab | Feb 2026 |
| Ketoconazole Tablets IP 200mg | Batch PGT241013Mfg Dec 2024 · Exp Nov 2026 | Affy ParenteralsHimachal Pradesh | The sample does not conforms to IP 2022 in respect of the Assay of KetoconazoleAssay | DTL, Baddi, Himanchal PradeshState lab | Jul 2025 |
| Ketoconazole & Zinc Pyrithione Shampoo (Ketocross Shampoo) | Batch L25Y2002Mfg Mar 2025 · Exp Feb 2027 | Om Sai Pharma PackUttarakhand | Assay of Zinc PyrithioneAssay | CDL KolkataCDSCO lab | Jun 2025 |
Showing 15 of 22 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.