Ingredient record · Asthma and allergy medicine
Montelukast: 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
4 entries containing Montelukast are on India's banned-drugs list, and 2 are banned today. 110 batches of medicines containing Montelukast failed a government lab test between March 2019 and September 2026, from 87 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
Brand answers:Is Montair-LC banned?
2
Banned combinations in force
2
Other listed orders (stayed, restricted, quashed)
110
Batches failed a lab test
Sep 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 43 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP | Batch FMT26015SLMfg Apr 2026 · Exp Mar 2028 | Shiva Biogenetic Laboratories Pvt. LtdHimachal Pradesh | The sample does not conform to IP in respect of DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Montelukast Sodium and Levocetirizine Hydrochloride Tablets | Batch ZDTY030Mfg Dec 2025 · Exp Nov 2027 | Pro-pharma Care Pvt. LtdUttarakhand | The sample dose not conform to I.P., in respect of Uniformity of content and DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Montelukast Sodium & Levocetirizine Hydrochloride Tablets IP | Batch T260356KMfg Mar 2026 · Exp Feb 2028 | Unispeed Pharmaceuticals Pvt. LtdHimachal Pradesh | The sample does not conform to IP in respect of DissolutionDissolution | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Montelukast Sodium & Levcocetirizine Hydrochloride Tablets IP | Batch D25M01MEMfg Dec 2025 · Exp Nov 2027 | Mapra Laboratories Pvt. LtdDaman & Diu | The sample does not conform to IP with respect to the DissolutionDissolution | SDTL, GuwahatiState lab | Sep 2026 |
| Levocetirizine Hydrochloride & Montelukast Sodium tablets IP | Batch UGT-25627LMfg May 2025 · Exp Apr 2027 | Ultra Drugs Pvt. LtdHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Sep 2026 |
| Levocetirizine Dihydrochloride & Montelukast Tablets IP | Batch LGP12/303/37Mfg Dec 2025 · Exp Nov 2027 | Logos PharmaHimachal Pradesh | The sample does not conform to IP with respect to the DissolutionDissolution | SDTL, GuwahatiState lab | Sep 2026 |
| Fexofenadine Hydrochloride & Montelukast Sodium Tablets | Batch GB25051Mfg Aug 2025 · Exp Jan 2028 | Devbhoomi PharmaceuticalsUttarakhand | The Content of MontelukastOther | FDAL, M. S Chhatrapatri Sambhajinagar, F.D.A Mahrasthra StateState lab | Sep 2026 |
| Montelukast sodium & Levocetirizine hydrochloride Tablets IP | Batch VRNT-933Mfg Mar 2025 · Exp Feb 2027 | Vrihaan Pharmaceuticals LLP | DissolutionDissolution | FDL, VadodaraState lab | Aug 2026 |
| Montelukast Tablets IP 10 mg | Batch T251209Mfg Dec 2025 · Exp Nov 2027 | Micron Pharmaceuticals | The sample does not conform to IP standards with respect to the test DissolutionDissolution | DTL, ThrissurState lab | Aug 2026 |
| Montelukast Sodium & Levocetirizine Hydrochloride Suspension | Batch DL508027Mfg Aug 2025 · Exp Jul 2027 | Renowed Life SciencesUttarakhand | Assay of Levocetirizine Hydrochloride.Assay | SFDTL, UttarakhandState lab | Aug 2026 |
| Montelukast & Levocetirizine Hydrochloride Syrup | Batch PTKLA004Mfg Nov 2025 · Exp Oct 2027 | Laborate Pharmaceuticals India Ltd (Unit-ii) 31Himachal Pradesh | Assay of Levocetirizine HydrochlorideAssay | SFDTL, UttarakhandState lab | Aug 2026 |
| Levocetirizine Hydrochloride and Montelukast Tablets | Batch 41046Mfg Nov 2025 · Exp Oct 2027 | Ronak Life Care Pvt. Ltd | The sample does not comply as per I.P. 2022 with respect to the test for Dissolution of Montelukast.Dissolution | RDTL, GuwahatiCDSCO lab | Aug 2026 |
| Levocetirizine Dihydrochloride,Montelukast Soidum & Ambroxol (SR) | Batch ITH002Mfg Aug 2025 · Exp Jul 2027 | Cis Life Care Pvt.Ltd.44-45 | The sample does not confom to IP 2022 requirements with respect to Uniformity of weightUniformity of weight/content | DTL,Dalgated Srinagar KashmirState lab | Aug 2026 |
| Levocetirizine & Montelukast Sodium Dispersible tablets | Batch ABC04ABAMfg Dec 2025 · Exp Nov 2027 | 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 | Batch ALL1169Mfg Aug 2024 · Exp Jul 2026 | Arcon LabsHimachal Pradesh | Content of MontelukastOther | SDT&RL, BhubaneswarState lab | Jun 2026 |
Showing 15 of 110 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.