Ingredient record · Asthma and allergy medicine
Montelukast: 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
4 entries containing Montelukast are on India's banned-drugs list, and 2 are banned today. 97 batches of medicines containing Montelukast failed a government lab test between March 2019 and July 2026, from 75 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
2
Banned combinations in force
2
Other listed orders (stayed, restricted, quashed)
97
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · some combos banned (2024)
Not banned
On the banned-drugs list
Montelukast 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 |
|---|---|---|---|---|---|
| Acebrophylline (SR) 200mg + Montelukast 10mg + Fexofenadine Hydrochloride 120mg TabletFixed-dose combination · cough-cold | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 13 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Etofylline + Theophylline Anhydrous eq. to Theophylline Hydrate + MontelukastFixed-dose combination · cough-cold | Banned | S.O. 3397(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levocetirizine + Montelukast + AcebrophyllineFixed-dose combination · cough-cold | Banned | S.O. 4573(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Montelukast + AcebrophyllineFixed-dose combination · cough-cold | Quashed | S.O. 912(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.
Top 30 of 40 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Levocetirizine & Montelukast Sodium Dispersible tablets | ABC04ABAMfg 2025-12 · Exp 2027-11 | Pure & Cure Healthcare Pvt. LtdUttarakhand | The sample does not conform to Label claim with respect to content of Montelukast in Montelukast sodium)Labelling | Drugs Testing Laboratory, Madurai-19State lab | Jul 2026 |
| Montelukast, Levocetrizine Dihydrochloride | ALL1169Mfg 2024-08 · Exp 2026-07 | Arcon LabsHimachal Pradesh | Content of MontelukastOther | SDT&RL, BhubaneswarState lab | Jun 2026 |
| Montelukast Tablets I.P. | CRT-250217Mfg 2025-02 · Exp 2027-01 | Civron PharmaceuticalsHimachal Pradesh | The sample is found to be Not of Standard Quality for the reason stated under Description.Description | CDL KolkataCDSCO lab | Jun 2026 |
| Levocetirizine HCl & Montelukast Sodium Syrup. | SL-151Mfg 2025-06 · Exp 2027-05 | Shivam Enterprises (Pharma Division)Himachal Pradesh | Assay Of Montelukast Sodium I.P. ? Less than prescribed limit.Assay | SDFTL US Nagar,UKState lab | Jun 2026 |
| Montelukast & Levocetrizine Hydrochloride Syrup | CRL2407068BMfg 2024-07 · Exp 2026-06 | Casca Remedies Pvt. LtdHaryana | Content of Levocetrizine Hydrochlroride & MontelukastOther | SDT&RL, BhubaneswarState lab | May 2026 |
| Levocetirizine Hydrochloride & Montelukast Syrup | JLH2523Mfg 2025-08 · Exp 2027-07 | Janveda Healthceuticals Pvt. LtdGujarat | Content of Levocetirizine Hydrochloride & MontelukastOther | FDL, VadodaraState lab | May 2026 |
| Montelukast Sodium and Levocetirizine Dihydrochloride Syrup | SP25990Mfg 2025-10 · Exp 2027-09 | Seejar Pharmaceuticalls | Assay for MontelukastAssay | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Levocetirizine Hydrochloride and Montelukast Sodium Tablets IP (5 mg/10 mg) | 310225017Mfg 2025-05 · Exp 2027-04 | Ravenbhel Healthcare Pvt. LtdJammu & Kashmir | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Levocetirizine Dihydrochloride and Montelukast Syrup | LR25J006Mfg 2025-10 · Exp 2027-09 | Rhombus Pharma Pvt. LtdGujarat | The sample received does not conform to I.P. 2022 with respect to the test for pHpH | CDTL, MumbaiCDSCO lab | Mar 2026 |
| Montelukast & Levocetirizine Dihydrochloride | E9AIY029Mfg 2025-08 · Exp 2027-07 | Pharma Force Lab (Unit-II)Himachal Pradesh | Assay of Montelukast Sodium IP & Levocetirizine Dihydrochloride IPAssay | FDTL,UttarakhandState lab | Feb 2026 |
| Levocetirizine Hydrochloride and Montelukast Sodium Tablets IP | UGT-25293LMfg 2025-03 · Exp 2027-02 | Ultra Drugs Pvt. LtdHimachal Pradesh | The sample does not conform to I.P.w.r.t. the test for DissolutionDissolution | SDTL, AssamState lab | Feb 2026 |
| Levocetirizine HCl & Montelukast Sodium Suspension | GL250137Mfg 2025-10 · Exp 2027-09 | Grownbury Pharmaceuticals Pvt. LtdUttarakhand | The sample does not conforms to Manufacturers specification with respect to the Test for pH, Total yeasts and molds count, Microbial contamination, Total bacterial countpH | CDTL, MumbaiCDSCO lab | Feb 2026 |
| Levocetirizine Dihydrochloride and Montelukast Sodium Syrup | AL-24002Mfg 2025-01 · Exp 2026-12 | Tridus RemediesBihar | The sample does not conform to claim with respect to Assay of Montelukast Sodium and Description.Assay | CDL, KolkataCDSCO lab | Jan 2026 |
| Levocetirizine DiHydrochloride, Montelukast | SRT-034Mfg 2024-02 · Exp 2026-01 | Sresan Pharmaceutical ManufacturerKarnataka | DescriptionDescription | SDT&RL, BhubaneswarState lab | Jan 2026 |
| Montelukast Sodium & Levocetirizine Hydrochloride Dispersible Tablets, (CIVIKAST-LC KID) | GT240841Mfg 2024-04 · Exp 2026-03 | Theon Pharmaceuticals LtdHimachal Pradesh | The sample does not conform to Schedule V of Drugs Rules 1940 with respect to the test Disintegration as per IPDisintegration | DTL Thrissur,KeralaState lab | Dec 2025 |
Showing 15 of 97 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.