Ingredient record · Antifungal
Itraconazole: 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
No combination containing Itraconazole is on India's banned-drugs list. 35 batches of medicines containing Itraconazole failed a government lab test between June 2021 and July 2026, from 34 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Itraconazole 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 Itraconazole 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 |
|---|---|---|---|
| Itraconazole | 26 | 25 | Jul 2026 |
| Itraconazole Ofloxacin Ornidazole Clobetasol Propionate | 2 | 2 | May 2025 |
| Itraconazole Itr | 1 | 1 | May 2025 |
| Itraconazole Trax | 1 | 1 | Jan 2025 |
| Itracharge | 1 | 1 | Dec 2024 |
| Canditral | 1 | 1 | Jun 2024 |
| Lytraco Itraconazole | 1 | 1 | Jun 2024 |
| Theozole | 1 | 1 | Aug 2022 |
| Belitra | 1 | 1 | Jun 2021 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Itraconazole, Capsules IP | CG25-0392AMfg 2025-11 · Exp 2027-10 | Athens Life Sciences Mauza-Rampur Jatten Nahan RoadHimachal Pradesh | AssayAssay | Lucknow LabState lab | Jul 2026 |
| Itraconazole 100mg IP | MC004Mfg 2025-07 · Exp 2027-06 | MK Healthcare | 1. The content of Itraconazole found to be 63.54 mg per capsule (63.54%) against labelled claim of 100 mg per capsule. 2. The composition on the label is not as per I.P monographLabelling | Govt Analyst PunjabState lab | Jul 2026 |
| Itraconazole Capsule IP 200 mg | IG25045Mfg 2025-06 · Exp 2027-05 | Innova Captab LtdHimachal Pradesh | The sample does not conform to I.P. w.r.to the tests for DissolutionDissolution | SDTL, GuwahatiState lab | Jun 2026 |
| Itraconazole Capsules BP 65 mg. | HC-2507123Mfg 2025-07 · Exp 2027-06 | Helax Health Care Pvt. LtdUttarakhand | The sample does not conform to claim as per B.P. with respect to the test for "Assay" and "Dissolution" of ItraconazoleAssay | RDTL, GuwahatiCDSCO lab | May 2026 |
| Itraconazole Capsule | BBC25I02AMfg 2025-12 · Exp 2027-11 | Bayberry Pharmaceuticals Pvt. LtdHimachal Pradesh | MisbrandadMisbranded | SDTL, ChhattisgarhState lab | May 2026 |
| Itraconazole Capsules USP 100 mg | ITR 19Mfg 2025-07 · Exp 2027-06 | Bal Pharma LtdKarnataka | The sample does not conform to U.S.P. with respect to Dissolution test.Dissolution | CDL, KolkataCDSCO lab | Apr 2026 |
| Itraconazole Capsules IP 200MG | AGC240040Mfg 2024-05 · Exp 2026-04 | Asterisk Healthcare V.P.O | The sample does not conform to I.P. w.r.t. the tests for Dissolution.Dissolution | SDTL, AssamState lab | Feb 2026 |
| Itraconazole Capsules USP | GCF0298Mfg 2025-07 · Exp 2027-06 | Digital VisionHimachal Pradesh | The sample does not comply as per U.S.P. 2025 with respect to the test for Dissolution .Dissolution | RDTL,GuwahatiCDSCO lab | Jan 2026 |
| Itraconazole Capsules BP 200 mg | R08GC2506AMfg 2025-08 · Exp 2027-07 | Rednex Pharmaceuticals Pvt. LtdKerala | The sample received does not conform to I.P. 2022 with respect to The test for Dissolution.Dissolution | CDTL, MumbaiCDSCO lab | Dec 2025 |
| Itraconazole Capsule IP 100mg | 1725-230Mfg 2025-04 · Exp 2027-09 | Zee Laboratories Ltd. Behind 47Himachal Pradesh | The sample does not conforrm to the IP with respect to DissolutionDissolution | DTL, JaipurState lab | Nov 2025 |
| Itraconazole Capsules BP 200 mg (Itradot-200 Capsules) | ALC-1509Mfg 2024-12 · Exp 2026-11 | Access Life ScienceHimachal Pradesh | Test for DissolutionDissolution | DTL, Bengaluru, KarnatakaState lab | Oct 2025 |
| Itraconazole Ofloxacin, Ornidazole & Clobetasol Propionate Cream (Fondastop C Cream) | 0-102Mfg 2023-09 · Exp 2025-08 | Spen Formulations Pvt. Ltd | The sample does not give High Performance Liquid Chromatographic and Thin Layer Chromatographic identification Test for the presence of itraconazole and Clobetasol Propionate.Identification | A.S Kambli Palghar-Zone-1 FDA, Lab MumbaiState lab | May 2025 |
| Itraconazole Capsules BP 100 mg (ITR 100 | 5007Mfg 2023-07 · Exp 2025-06 | Orley Laboratories Pvt. Ltd. 1817Gujarat | The sample does not comply with B.P requirements for Dissolution TestDissolution | A.S Kambli Palghar-Zone-1 FDA, Lab MumbaiState lab | May 2025 |
| Itraconazole Capsules BP 100 mg (Fungis-100) | C4050Mfg 2024-06 · Exp 2026-05 | Merril Pharma Pvt. LtdGujarat | DissolutionDissolution | CDL, KolkataCDSCO lab | Mar 2025 |
| Itraconazole Capsules IP 100 mg | CTA-01Mfg 2024-02 · Exp 2026-01 | Agron Remedies Pvt. LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiCDSCO lab | Jan 2025 |
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.