Product record

Itraconazole: batches declared Not of Standard Quality

Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts, Jan 2019 to Sep 2026

33 batches of products named "Itraconazole" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between January 2022 and September 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.

Records by type

33 records linked to Itraconazole in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.

0Banned or prohibited
0Recalled or suspended
33Failed a lab test
0Regulatory notice
Primary government sourceTier 1: government primary source

CDSCO drug alerts: Not of Standard Quality and spurious drugs

CDSCO · CDSCO monthly NSQ alerts, Jan 2022 to Sep 2026

View original document

Scope. A failed batch is not a verdict on every pack of this product. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.

33
NSQ batches
31
Manufacturers
Dissolution
Most common reason
Sep 2026
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
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
Batch C60015Mfg Jan 2026 · Exp Dec 2027 Zenith Drugs Pvt. LtdMadhya Pradesh Test for DissolutionDissolution RDTL, Bellary, KarnatakaState lab Sep 2026
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
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
Batch MEX-055Mfg Feb 2026 · Exp Jan 2028 Manja Pharmaceuticals Pvt. Ltd DissolutionDissolution RDTL, Bellary, KarnatakaState lab Aug 2026
Batch MEX-042Mfg Dec 2025 · Exp Nov 2027 Manja Pharmaceuticals Pvt. Ltd Test for DissolutionDissolution RDTL, Hubli, KarnatakaState lab Aug 2026
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
Batch CG25-0392AMfg Nov 2025 · Exp Oct 2027 Athens Life Sciences Mauza-Rampur Jatten Nahan RoadHimachal Pradesh AssayAssay Lucknow LabState lab Jul 2026
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
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
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
Batch BBC25I02AMfg Dec 2025 · Exp Nov 2027 Bayberry Pharmaceuticals Pvt. LtdHimachal Pradesh MisbrandadMisbranded SDTL, ChhattisgarhState lab May 2026
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
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
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
Batch R08GC2506AMfg Aug 2025 · Exp Jul 2027 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
Batch 1725-230Mfg Apr 2025 · Exp Sep 2027 Zee Laboratories Ltd. Behind 47Himachal Pradesh The sample does not conforrm to the IP with respect to DissolutionDissolution DTL, JaipurState lab Nov 2025
Batch ALC-1509Mfg Dec 2024 · Exp Nov 2026 Access Life ScienceHimachal Pradesh Test for DissolutionDissolution DTL, Bengaluru, KarnatakaState lab Oct 2025
Batch C4050Mfg Jun 2024 · Exp May 2026 Merril Pharma Pvt. LtdGujarat DissolutionDissolution CDL, KolkataCDSCO lab Mar 2025
Batch CTA-01Mfg Feb 2024 · Exp Jan 2026 Agron Remedies Pvt. LtdUttarakhand DissolutionDissolution RDTL GuwahatiCDSCO lab Jan 2025
Batch 24S2GCA2 82Mfg Apr 2024 · Exp Mar 2026 Synokem Pharmaceuticals LtdUttarakhand DissolutionDissolution RDTL GuwahatiCDSCO lab Nov 2024
Batch 23K-C354Mfg Feb 2024 · Exp Jan 2026 Orison Pharma InternationalHimachal Pradesh DissolutionDissolution RDTL GuwahatiCDSCO lab Nov 2024
Batch IG23038Mfg May 2023 · Exp Apr 2025 InnovaCaptab LtdHimachal Pradesh DissolutionDissolution RDTL GuwahatiCDSCO lab Nov 2024
Batch WC819CMfg Nov 2023 · Exp Oct 2025 Saphnix Life SciencesHimachal Pradesh DissolutionDissolution RDTL GuwahatiCDSCO lab Nov 2024
Batch IZC2401Mfg Apr 2024 · Exp Mar 2026 Modern LaboratoriesMadhya Pradesh DissolutionDissolution SDTL Agartala, TripuraState lab Oct 2024
Batch IZC2401Mfg Apr 2024 · Exp Mar 2026 Modern LaboratoriesMadhya Pradesh DissolutionDissolution SDTL Agartala, TripuraState lab Oct 2024
Batch UC-23240AMfg Oct 2023 · Exp Sep 2025 Ultra Drugs Pvt. LtdHimachal Pradesh DissolutionDissolution CDL KolkataCDSCO lab Jul 2024
Batch MAR-24154Mfg Mar 2024 · Exp Feb 2026 Bonsai PharmaHimachal Pradesh DissolutionDissolution CDL KolkataCDSCO lab Jul 2024
Batch LGL07/150/ 20Mfg Jul 2022 · Exp Jun 2024 Logos PharmaHimachal Pradesh DissolutionDissolution RDTL GuwahatiState lab Dec 2023
Batch 2304104Mfg Apr 2023 · Exp Mar 2025 Impulse Pharma Pvt. LtdMaharashtra DissolutionDissolution CDTL MumbaiCDSCO lab Dec 2023
Batch Z22-293Mfg Mar 2022 · Exp Feb 2024 Zee Laboratories LtdHimachal Pradesh DissolutionDissolution RDTL ChandigarhCDSCO lab Jul 2023
Batch CH2006AMfg Aug 2022 · Exp Jul 2024 Navkar LifesciencesHimachal Pradesh DissolutionDissolution RDTL GuwahatiState lab Jan 2023
Batch MC21250Mfg Apr 2021 · Exp Mar 2023 Mascot Health Series Pvt. LtdUttarakhand DisintegrationDisintegration RDTL ChandigarhCDSCO lab Jan 2022

How to use this. Match the batch number on your strip or bottle against the list. If your batch is listed, return it to the pharmacy and ask for a replacement; if not, the product is not on any alert as of September 2026. Check any batch number.