Ingredient record · Antifungal
Itraconazole: 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 Itraconazole is on India's banned-drugs list. 42 batches of medicines containing Itraconazole failed a government lab test between June 2021 and September 2026, from 40 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 | 33 | 31 | Sep 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 200mg | Batch B23225007Mfg Aug 2025 · Exp Jul 2027 | Torque Pharmaceuticals Pvt. Ltd | The sample does not conform to claim with respect to test for Dissolution.Dissolution | CDL, KolkataCDSCO lab | Sep 2026 |
| Itraconazole Capsules 100 mg | Batch C60015Mfg Jan 2026 · Exp Dec 2027 | Zenith Drugs Pvt. LtdMadhya Pradesh | Test for DissolutionDissolution | RDTL, Bellary, KarnatakaState lab | Sep 2026 |
| Itraconazole Capsules IP 200 mg | Batch 02T65Mfg Dec 2025 · Exp Nov 2027 | Kivi Labs LtdGujarat | The sample does not conform to I.P. with respect to the Dissolution test.Dissolution | CDL, KolkataCDSCO lab | Aug 2026 |
| Itraconazole Capsules IP | Batch AC-662HMfg Nov 2025 · Exp Oct 2027 | Azot Life SciencesHimachal Pradesh | The sample does not conform to I.P. with respect to test for Dissolution.Dissolution | CDL, KolkataCDSCO lab | Aug 2026 |
| Itraconazole Capsules 200 mg | Batch MEX-055Mfg Feb 2026 · Exp Jan 2028 | Manja Pharmaceuticals Pvt. Ltd | DissolutionDissolution | RDTL, Bellary, KarnatakaState lab | Aug 2026 |
| Itraconazole Capsules 100 mg | Batch MEX-042Mfg Dec 2025 · Exp Nov 2027 | Manja Pharmaceuticals Pvt. Ltd | Test for DissolutionDissolution | RDTL, Hubli, KarnatakaState lab | Aug 2026 |
| Itraconazole Capsule 200mg | Batch B23225009Mfg Oct 2025 · Exp Sep 2027 | Torque Pharmaceuticals Pvt. Ltd 13B-14 | The Sample Does Not Comply with IP requirements for the Dissolution test,The Sample is Declared As Misbranded Vide Rule 96 and Section 17(b) of Drugs And Cosmetics Act, 1940 And Rules 1945, as the Manufacturer does not stated IP on Sample Carton and Blister.Dissolution | FDAL, MumbaiState lab | Aug 2026 |
| Itraconazole, Capsules IP | Batch CG25-0392AMfg Nov 2025 · Exp Oct 2027 | Athens Life Sciences Mauza-Rampur Jatten Nahan RoadHimachal Pradesh | AssayAssay | Lucknow LabState lab | Jul 2026 |
| Itraconazole 100mg IP | Batch MC004Mfg Jul 2025 · Exp Jun 2027 | 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 | Batch IG25045Mfg Jun 2025 · Exp May 2027 | 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. | Batch HC-2507123Mfg Jul 2025 · Exp Jun 2027 | 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 | Batch BBC25I02AMfg Dec 2025 · Exp Nov 2027 | Bayberry Pharmaceuticals Pvt. LtdHimachal Pradesh | MisbrandadMisbranded | SDTL, ChhattisgarhState lab | May 2026 |
| Itraconazole Capsules USP 100 mg | Batch ITR 19Mfg Jul 2025 · Exp Jun 2027 | 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 | Batch AGC240040Mfg May 2024 · Exp Apr 2026 | 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 | Batch GCF0298Mfg Jul 2025 · Exp Jun 2027 | 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 |
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.